XScribe
Cardiac Stress Testing System
18manufacturers in China registered for this device type
22catalogue numbers in this listing
21510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (10), Jiangsu (2), Beijing (1). 8 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 |
| Tianjin Choice Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 12 |
| Yahorng Dongguan Electronic Co Ltd | Guangdong | Guangdong | Contract manufacturer | 8 |
| Omron (Dalian) Co., Ltd. (Plant 1) | Dalian | Liaoning | Contract manufacturer | 7 |
| Wuhan Strong Electronics | Wuhan | Hubei | Contract manufacturer | 6 |
| Regent Electron Suzhou Co., Ltd. | Wujiang | Jiangsu | Contract manufacturer | 5 |
| Ryder Electronics (Shenzhen) Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Beijing Choice Electronic Technololgy Co., Ltd. | Beijing | Beijing | Repacker / relabeller | 30 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
Showing 12 of 18. All 18 manufacturers in China registered for Electrocardiograph
Record
| Listed by | Mortara Instrument, Inc., United States |
|---|---|
| FDA product code | DPS |
| Device type | Electrocardiograph |
| Device class | Class 2 |
| Regulation | 21 CFR 870.2340 |
| 510(k) | K022618 |
| Record published | 2017-09-12 |
| Record revised | 2020-06-29 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment humidity up to 80 % RH; Storage environment temperature up to 149 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| XSCRIBE-6AA-XFAXB | In distribution | |
| XSERV-6AA-XXXXD | In distribution | |
| XSCRIBE-6AC-AAAXX | In distribution | |
| XSCRIBE-6AC-AAAAX | In distribution | |
| XSCRIBE-6AA-AFAXB | In distribution | |
| XSCRIBE-6AC-AEAXX | In distribution | |
| XSCRIBE-6BD-AFAAA | In distribution | |
| XSCRIBE-6AA-AAAAA | In distribution | |
| XSCRIBE-6BB-AAAXA | In distribution | |
| XSCRIBE-6EB-AAAXB | In distribution | |
| XSERV-6AA-XXXXX | In distribution | |
| XSCRIBE-6AA-AFAAA | In distribution | |
| XSCRIBE-6GD-AEAAA | In distribution | |
| XSCRIBE-6AC-ACAXX | In distribution | |
| XSCRIBE-6BD-AFAAB | In distribution | |
| XSERV-6AA-XXXXB | In distribution | |
| 11014-017-50 | In distribution | |
| XSCRIBE-6AC-AXAXA | In distribution | |
| XSCRIBE-5AX-XXBRZ | In distribution | |
| XSCRIBE-6AA-AFAAB | In distribution | |
| 11014-018-50 | In distribution | |
| XSCRIBE-6DD-CDBAX | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Welch Allyn, Inc. | Welch Allyn, Inc. | 1,734 |
| M Series Biphasic | Zoll Medical Corporation | 93 |
| ELI 380 | Mortara Instrument, Inc. | 69 |
| Patient Cable Lead Set | Mortara Instrument, Inc. | 56 |
| ELI 250c | Mortara Instrument, Inc. | 50 |
| Lutech | Lutech Industries | 49 |
| ELI 150c | Mortara Instrument, Inc. | 47 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 41 |
| ELI 280 | Mortara Instrument, Inc. | 41 |
| Electrocardiograph | Edan Instruments, Inc. | 38 |
| Q-Stress | Mortara Instrument, Inc. | 25 |
| Spacelabs Healthcare | Spacelabs Healthcare (Washington), Inc | 21 |
Showing 12 of 177. All products under Electrocardiograph
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152944 | 2016-01-06 |
| K142105 | 2014-09-05 |
| K122073 | 2012-08-02 |
| K120865 | 2012-07-19 |
| K102206 | 2011-02-18 |
| K101403 | 2010-07-02 |
| K101115 | 2010-06-18 |
| K100127 | 2010-04-16 |
| K093339 | 2010-02-19 |
| K092663 | 2009-12-14 |
| K082946 | 2008-12-29 |
| K070539 | 2007-03-15 |
| K062677 | 2006-11-15 |
| K031182 | 2003-07-25 |
| K022618 | 2002-09-06 |
| K930558 | 1993-04-27 |
| K922927 | 1992-11-10 |
| K864580 | 1987-02-20 |
| K861850 | 1986-08-28 |
| K861851 | 1986-08-28 |
| K832050 | 1983-12-13 |
Recalls Naming This Product
5 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Baxter Healthcare Corporation | 510(k) number | 2024-10-11 | Class II | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this coul | 2461 units | |
| Baxter Healthcare Corporation | 510(k) number | 2024-10-11 | Class II | Software design | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If the system receiving the DICOM file (e.g., Picture Archiving and Communication System (PACS)) relies solely on the UID to accept exams, this coul | 766 units | |
| Baxter Healthcare Corporation | 510(k) number | 2023-12-08 | Class II | Software design | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. | 4687 units | |
| Baxter Healthcare Corporation | 510(k) number | 2023-12-08 | Class II | Software design | Potential distortion identified in electrocardiogram (ECG) readings when the Source Consistency Filter (SCF) is enabled. | 2985 units | |
| Welch Allyn Inc Mortara | 510(k) number | 2020-03-18 | Class II | Device Design | Impacted Welch Allyn products may not meet the Defibrillation Withstand requirements of EN/IEC 60601-2-25 Medical Electrical Equipment. | 78,521 units total | 2026-02-09 |
Recalls
1 of these is 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 |
|---|---|---|---|---|---|
| 2015-05-29 | Class II | Software design | Mortara Instrument, Inc. has recently become aware of a potential safety hazard involving our ELI 380 electrocardiograph. When used in a particular workflow, acquired ECG waveforms for one patient may become associated with the patient demo | 176 | 2015-08-05 |
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.