Carescape ECG
Carescape ECG MKE101 Module
9manufacturers in China registered for this device type
1catalogue number
34510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
| Shenzhen Comen Medical Instruments Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 24 |
| Contec Medical Systems Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 22 |
| Guangdong Biolight Meditech Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 19 |
| Shanghai Draeger Medical Instrument Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| General Meditech, Inc. | Shenzhen | Guangdong | Complaint-file establishment | 3 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | MHX |
| Device type | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K200494 |
| Record published | 2020-04-06 |
| Record revised | 2026-01-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -30 to 70 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 50 to 108 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MKE101 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 326 |
| Welch Allyn, Inc. | Welch Allyn, Inc. | 266 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden Corp. | 205 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | Nihon Kohden America, Inc. | 139 |
| Surveyor Central | Mortara Instrument, Inc. | 71 |
| Tempus Pro | Remote Diagnostic Technologies Ltd. | 44 |
| Surveyor S12 | Mortara Instrument, Inc. | 38 |
| Ultraview | Spacelabs Healthcare (Washington), Inc | 29 |
| Surveyor S19 | Mortara Instrument, Inc. | 26 |
| Vital Signs™ | AirLife Finland Oy | 23 |
| Patient Monitor | Edan Instruments, Inc. | 22 |
| Telemetry Accessories | Philips Medizin Systeme Böblingen GmbH | 21 |
Showing 12 of 589. All products under Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253277 | 2026-07-24 |
| K242562 | 2025-07-09 |
| K222586 | 2022-12-21 |
| K221904 | 2022-12-20 |
| K213234 | 2022-04-12 |
| K213490 | 2022-04-01 |
| K201941 | 2020-11-04 |
| K170155 | 2017-06-06 |
| K141963 | 2015-02-05 |
| K092369 | 2010-02-24 |
| K092027 | 2009-08-28 |
| K091594 | 2009-07-29 |
| K090702 | 2009-04-15 |
| K083750 | 2009-03-23 |
| K080251 | 2008-06-20 |
| K080157 | 2008-03-24 |
| K073462 | 2008-01-11 |
| K073203 | 2007-11-29 |
| K071073 | 2007-05-11 |
| K060833 | 2006-08-01 |
| K051367 | 2005-06-20 |
| K042642 | 2004-11-03 |
| K040458 | 2004-06-03 |
| K033964 | 2004-01-15 |
| K033492 | 2003-11-24 |
| K033304 | 2003-11-12 |
| K033365 | 2003-11-06 |
| K032369 | 2003-08-15 |
| K031376 | 2003-07-16 |
| K022834 | 2003-05-13 |
| K031320 | 2003-05-06 |
| K030575 | 2003-03-21 |
| K030431 | 2003-02-26 |
| K012915 | 2002-03-21 |
Recalls Naming This Product
2 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 |
|---|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | 510(k) number | 2025-09-26 | Class II | Component change control | Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and pot | 5935 | |
| GE Medical Systems, LLC | 510(k) number | 2020-06-22 | Class II | Software Design Change | CARESCAPE ONE may not provide visual and audible alarms for Ventricular Fibrillation (V Fib), if V Fib occurs at the time CARESCAPE ONE is docked to a CARESCAPE B450/B650/B850 host monitor. | 8,414 units | 2024-08-19 |
Recalls
7 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 |
|---|---|---|---|---|---|
| 2026-04-24 | Class II | Software design | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the C | 2187 units | |
| 2026-04-24 | Class II | Software design | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the C | 2366 units | |
| 2026-04-24 | Class II | Software design | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the C | 476 units | |
| 2026-04-24 | Class II | Software design | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the C | 14 units | |
| 2026-04-24 | Class II | Software design | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the C | 1249 units | |
| 2026-04-24 | Class II | Software design | GE HealthCare has become aware of an unlikely situation where potential loss of ECG and SpO2 monitoring involving ApexPro CARESCAPE Telemetry Server (CTS) v5.0 and v6.0, can result from a persistent NO COMM or OFF NETWORK condition at the C | 7 units | |
| 2017-07-13 | Class II | Software Design Change | Device does not produce a visual or audible impedance respiration APN alarm when an impedance respiration apnea event occurs. | 1,196 (1,176 US; 20 OUS) | 2021-04-01 |
| 2004-01-27 | Not classified | Other | The potential exists for external electrical noise to be processed as irregular pacing thereby masking potential asystole events. | 36 | 2009-10-05 |
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.