R Series
Defibrillator ,MAIN, R SERIES, ALS, WI-FI, NELLCOR, 3/5 LD, STD ECG, AC PWR, PACE, SPO2, ETCO2, CF/USB, DMST, REFURB
3manufacturers in China registered for this device type
216catalogue numbers in this listing
35510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
All of them in Guangdong. 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Amphenol Alden Products Company | Shenzhen | Guangdong | Contract manufacturer | 24 |
| EMI (Dongguan) Asia Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
Record
| Listed by | Zoll Medical Corporation, United States |
|---|---|
| FDA product code | MKJ |
| Device type | Automated External Defibrillators (Non-Wearable) |
| Device class | Class 3 |
| Regulation | 21 CFR 870.5310 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K990762 |
| Record published | 2014-09-19 |
| Record revised | 2026-02-09 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
| Storage | Handling environment temperature 0 to 55 °C; Storage environment temperature -20 to 60 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure from 0 KiloPascal |
| Distribution end date | 2026-01-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 30001005201210013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10020002001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001005201230013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001009001330012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001003101130013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001003101030012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001001001010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001003101110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30000003101110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001002001130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001001001110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001002101010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10720005201310012-3 | In distribution | |
| 10001009001310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000001010013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001009001210013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30310004101030012 | In distribution | |
| 30001000001010362 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001004101110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000007201310012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30520003121110013 | In distribution | |
| 30000001001030013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000002001030012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001009201210013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001000001030012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000001030013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001009201310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001000001030013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001001001130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10520001001110013-1 | In distribution | |
| 30000004101110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001000301110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001007201330013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001001001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001006001230012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30310009001230012 | In distribution | |
| 30000000520131012 | 10.2″ X 10.3″ X 8.7″ | In distribution |
| 30001002001030012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001009001310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001003101110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10120000001110012-2 | In distribution | |
| 10000003101110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10001000001130012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30320000301130012 | In distribution | |
| 10000000001030013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10520005201310013-1 | In distribution | |
| 10001000001130013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10001004101110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001005201230012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000006001310012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10001000301110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001009201210012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30110000001030012 | In distribution | |
| 30000002001110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000001001010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001002001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000005201310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001005201210011 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10520007201310013-2 | In distribution | |
| 30001000001110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10120007201310012-3 | In distribution | |
| 30000005201230013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10520007201310013-3 | In distribution | |
| 10000006201310012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30000003101010013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000001130013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000006201310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001006001310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000002101010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000005201310011 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000005201230012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001000001030013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001003101130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30320000001010012 | In distribution | |
| 30000006201310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001000001010012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001004101010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001005201310013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001000001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001000001010363 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001003101010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30310006001230012 | In distribution | |
| 10001000001110013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001001001130013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001003101010013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10120001001110012-1 | In distribution | |
| 10000003101110013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001005201330012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000002001130013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001000001110362 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001001001110013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10520005201310013-3 | In distribution | |
| 30000000301130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10120007201310012-2 | In distribution | |
| 10001007201310012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10720005201310012-2 | In distribution | |
| 30000001001110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000003101110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000000001130012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10000005201330012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001009001230012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000005201310013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10001006201310012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30000001001130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000004101110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001000301110363 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000002001130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001000001010013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000001010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001009001330012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000001001130013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001000301130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10520005201310013-2 | In distribution | |
| 30001006001330013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001006001310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000000001010013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30220005201310013 | In distribution | |
| 30000006201330012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001005201330012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10120000001110012-1 | In distribution | |
| 30001005201310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001007201310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001006201330012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000001130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000000001010012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10000000001130013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30000003101130013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000005201210012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001003101110013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001005201210012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000003101010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10520001001110013-2 | In distribution | |
| 30000000001030012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000005201310012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001002001130013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000001001010011 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10520000001110013-3 | In distribution | |
| 30001000301110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001005201310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000005201210013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 1009-000208-40 | In distribution | |
| 10000007201310013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30000001001110011 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001006201330013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30520001011110013 | In distribution | |
| 10120001001110012-3 | In distribution | |
| 30001004101110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10520007201310013-1 | In distribution | |
| 30001006001330012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000000001110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001009001210012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10120000001110012-3 | In distribution | |
| 30320006001330012 | In distribution | |
| 10110000001010012 | In distribution | |
| 30001009201310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001004101030012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000001001110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30000004101130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30320009201330012 | In distribution | |
| 30001000001010012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000301110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001005201330013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001001001030013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001001001110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10001003101130012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30000001001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001009001310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001009001310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000001001130013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001001001130013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10000003101130012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30320009001330012 | In distribution | |
| 30001007201310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001006201310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000007201310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000002001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001006001310012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10000001001110013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10120001001110012-2 | In distribution | |
| 10520000001110013-1 | In distribution | |
| 10520001001110013-3 | In distribution | |
| 10000000301110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001000301110362 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000007201330013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001007201330012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001006001310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000001110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001000001030012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001000001010013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30310009201230012 | In distribution | |
| 30000006201330013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001007201310013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30000005201310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001000301110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000004101110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10520000001110013-2 | In distribution | |
| 30001003101110013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000006001310012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000005201330013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10001000001110012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001009001330013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000000301110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001001001110011 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000005201330012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001006201310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001004101130012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001002001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000002001110012 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10000000001110013 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 10001005201310012 | 8.2″ x 10.5″ x 12.5″ | In distribution |
| 30001005201310011 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 10120007201310012-1 | In distribution | |
| 30001000001130013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30000007201310013 | 6.8″ x 10.3″ x 8.2″ | In distribution |
| 30001003101010363 | 6.8″ x 10.3″ x 8.2″ | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| X Series | Zoll Medical Corporation | 862 |
| E Series | Zoll Medical Corporation | 571 |
| M Series | Zoll Medical Corporation | 219 |
| Lifepak® 15 monitor/defibrillator | Physio-Control, Inc. | 188 |
| AED Plus | Zoll Medical Corporation | 124 |
| Lifepak® 12 defibrillator/monitor | Physio-Control, Inc. | 122 |
| Lifepak CR Plus and Lifepak Express defibrillators | Physio-Control, Inc. | 111 |
| M Series Biphasic | Zoll Medical Corporation | 111 |
| PadPro | ConMed Corporation | 96 |
| R&D Batteries, Inc. | R & D Batteries, Inc. | 71 |
| Lifepak® 20 and Lifepak 20e defibrillator/monitors | Physio-Control, Inc. | 59 |
| AED 3 | Zoll Medical Corporation | 57 |
Showing 12 of 312. All products under Automated External Defibrillators (Non-Wearable)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K142915 | 2014-12-03 |
| K141774 | 2014-11-19 |
| K133484 | 2014-08-01 |
| K122839 | 2012-12-13 |
| K110978 | 2011-05-13 |
| K110742 | 2011-04-13 |
| K110526 | 2011-03-25 |
| K091561 | 2010-09-23 |
| K090989 | 2009-09-23 |
| K081828 | 2008-12-09 |
| K080903 | 2008-12-04 |
| K072430 | 2007-11-06 |
| K062537 | 2007-02-28 |
| K062177 | 2006-12-13 |
| K060559 | 2006-08-17 |
| K051475 | 2005-06-24 |
| K051076 | 2005-05-13 |
| K042007 | 2005-04-07 |
| K041892 | 2005-02-04 |
| K042417 | 2004-10-05 |
| K033474 | 2004-05-21 |
| K032439 | 2003-11-05 |
| K011541 | 2002-04-11 |
| K011388 | 2002-03-25 |
| K010257 | 2001-02-28 |
| K993036 | 2000-02-28 |
| K991556 | 1999-10-21 |
| K990762 | 1999-09-03 |
| K982992 | 1999-03-11 |
| K972241 | 1998-03-16 |
| K942344 | 1995-03-13 |
| K942850 | 1995-02-10 |
| K943698 | 1994-12-28 |
| K932028 | 1993-10-08 |
| K932931 | 1993-10-07 |
Recalls
23 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2025-02-13 | Class II | Unknown/Undetermined by firm | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | 73 units | |
| 2025-02-13 | Class II | Unknown/Undetermined by firm | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | 960 units | |
| 2025-02-13 | Class II | Unknown/Undetermined by firm | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | 1312 units | |
| 2025-02-13 | Class II | Unknown/Undetermined by firm | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | 8,744 units | |
| 2025-02-13 | Class II | Unknown/Undetermined by firm | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | 63,607 units | |
| 2025-02-13 | Class II | Unknown/Undetermined by firm | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | 7,221 units | |
| 2025-02-13 | Class II | Unknown/Undetermined by firm | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | 56,981 units | |
| 2025-02-13 | Class II | Unknown/Undetermined by firm | The potential for devices to fail their self-test as a result of prolonged exposure to extreme environments (temperature and/or humidity). | 2268 units | |
| 2024-05-31 | Class II | Use error | G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film | 14885 | |
| 2019-06-12 | Class II | Device Design | There is a potential for the device to fail to deliver energy to the patient. | 1,969 | |
| 2019-06-04 | Class II | Process control | Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications. | 5 devices | 2021-11-15 |
| 2017-08-04 | Class II | Process control | A portion of one lot of ZOLL OneStep Complete Electrodes for adults will cause the defibrillator to deliver pediatric energy levels instead of adult energy levels when used with the ZOLL R Series Defibrillator. Defective electrodes will dis | 3400 | 2018-08-31 |
| 2016-01-14 | Class II | Nonconforming Material/Component | Defibrillation electrodes may increase electrical impedance over time. If impedance becomes too high, the AED will fail the electrode self-test and it will not be Rescue Ready, the AED STATUS INDICATOR will be RED and the AED will beep. Thi | 10,943 | 2016-12-21 |
| 2014-09-16 | Class II | Material/Component Contamination | Product sterility is not assured | 237 cases (6/case) | 2016-05-03 |
| 2014-09-16 | Class II | Material/Component Contamination | Product sterility is not assured | 41 singles | 2016-05-03 |
| 2014-09-16 | Class II | Material/Component Contamination | Product sterility is not assured | 18 singles | 2016-05-03 |
| 2014-09-16 | Class II | Material/Component Contamination | Product sterility is not assured | 193 cases (6/case) | 2016-05-03 |
| 2014-08-26 | Class II | Process control | Sterility of device is not assured | 100 cases =600 units | 2016-05-03 |
| 2014-08-26 | Class II | Process control | Sterility of device is not assured | 12 each | 2016-05-03 |
| 2014-08-26 | Class II | Process control | Sterility of device is not assured | 198 cases | 2016-05-03 |
| 2014-03-05 | Class II | Software design | Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset Loop and cannot be used | 3,169 units | 2021-01-29 |
| 2013-03-12 | Class II | Nonconforming Material/Component | Medsoultions4U Multi-Function Lifepak Electrodes, manufactured with an incorrect wire connector which could not interface with the defibrillators | 30 cases (300 electordes) | 2015-06-17 |
| 2012-08-16 | Class II | Process control | Shipped with incorrect software | 11 units | 2012-09-19 |
| 2012-01-13 | Not classified | Process control | The affected Automated External Defibrillators (AEDs) contains a circuit board manufactured with a component that may fail unexpectedly due to a supplier manufacturing defect. If the component were to fail during a rescue attempt, the AED | 11,019 units (6142 units in the US and 4877 units internatio | 2013-09-27 |
| 2011-06-30 | Not classified | Device Design | Cardiac Science Corporation (CSC) has identified two errors, 0x48 and 0x99, that have repeatedly occurred during a device self-test in the G3 installed base over the last 6 years. These self test errors cause the device to enter into a ser | 195,739 units in US | 2014-02-13 |
| 2011-06-29 | Not classified | Nonconforming Material/Component | Cardiac Science Corporation (CSC) intent to end service support and discontinue accessory sales of Powerheart G2 Automated External Defibrillators. Customers are recommended to choose a replacement AED prior to the current AED displaying a | 48,700 units (41396 units in US; 7304 units Internationally) | 2011-12-20 |
| 2011-04-21 | Not classified | Software design | Zoll E Series BLS Defibrillator may fail to auto charge and deliver energy | 874 units | 2014-01-23 |
| 2010-04-28 | Not classified | Nonconforming Material/Component | Some units may be non-operational during a rescue, due to a defective PCB interconnect on traces connected to the reed relay. This will result in an inability to analyze the patient’s heart rhythm or deliver therapy during a rescue. | 130 units | 2011-12-08 |
| 2010-03-24 | Not classified | Software design | Device issued Shock Advised message but failed to auto-charge the defibrillator. | 1383 units | 2014-01-23 |
| 2010-02-03 | Not classified | Nonconforming Material/Component | A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy. | 1 | 2011-12-08 |
| 2010-02-03 | Not classified | Nonconforming Material/Component | A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy. | 5104 | 2011-12-08 |
| 2010-02-03 | Not classified | Nonconforming Material/Component | A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy. | 1006 | 2011-12-08 |
| 2010-02-03 | Not classified | Nonconforming Material/Component | A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy. | 1 | 2011-12-08 |
| 2010-02-03 | Not classified | Nonconforming Material/Component | A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy. | 2640 | 2011-12-08 |
| 2010-02-03 | Not classified | Nonconforming Material/Component | A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy. | 1162 | 2011-12-08 |
| 2010-02-03 | Not classified | Nonconforming Material/Component | A component of the AED device may fail during a rescue attempt and the AED will not be able to deliver therapy. | 426 | 2011-12-08 |
| 2009-12-18 | Not classified | Other | The K302 relay switch of the G3 series AED product line may experience an early failure. If the K302 contacts are open at the time of rescue, there is a possible delay in therapy or failure to deliver therapy. | 332 units | 2011-12-08 |
| 2009-11-13 | Not classified | Process control | Potential for devices not to deliver therapy | 45518 | 2014-10-24 |
| 2009-11-13 | Not classified | Process control | Potential for devices not to deliver therapy | 8488 | 2014-10-24 |
| 2009-11-13 | Not classified | Process control | Potential for devices not to deliver therapy | 4165 | 2014-10-24 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P160008 | 2026-05-07 | HeartSines samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories | Heartsine Technologies, Ltd |
| P170018 | 2025-11-06 | LIFEPAK® CR2 Automated External Defibrillator | Physio-Control, Inc. |
| P160032 | 2025-07-03 | Defibtech Lifeline; Defibtech Lifeline AUTO; Defibtech Lifeline VIEW; Defibtech Lifeline VIEW AUTO; Defibtech Lifeline E | Defibtech, LLC |
| P210015 | 2025-01-29 | Avive Automated External Defibrillator (AED) System | Avive Solutions Inc |
| P200005 | 2024-01-09 | TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors | TZ Medical, Inc. |
| P200007 | 2023-06-23 | HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads | Graphic Controls D.B.A. Vermed |
| P200004 | 2022-06-16 | ConMed PadPro Multifunction Electrodes | ConMed Corporation |
| P160012 | 2021-07-08 | Infant/Child Reduced Energy Defibrillation Electrodes | Physio-Control, Inc. |
| P160033 | 2021-06-14 | Powerheart G5 AED | Zoll Medical Corporation |
| P190013 | 2021-02-02 | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) | AED Battery Exchange, LLC |
| P180028 | 2020-08-22 | HeartStart FRx Defibrillator | Philips Medical Systems Technologies Ltd |
| P190007 | 2020-08-07 | Cardinal Health Multifunctional Defibrillation Electrode | Cardinalhealth |
| P160022 | 2020-06-11 | X Series and Propaq MD | Zoll Medical Corporation |
| P160015 | 2020-06-05 | AED 3 Defibrillator with Uni-Padz | Zoll Medical Corporation |
| P160028 | 2020-05-11 | Philips HeartStart FR3 Defibrillator | Philips Medical Systems Technologies Ltd |
| P160026 | 2020-02-13 | LIFEPAK Automated External Defibrillators (AEDs) | Physio-Control, Inc. |
| P160034 | 2019-08-20 | Powerheart® G3 Pro AED | Zoll Medical Corporation |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.