B105M
B105M VSP4 ATO Model
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) | K242562 |
| Record published | 2026-06-12 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 5 to 35 °C; Handling environment humidity 15 to 90 % RH; Handling environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| B105M Patient Monitor | 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
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| GE Healthcare Finland OY | UDI-DI | 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 | 7408 |
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.