Carescape Central Station
Carescape Central Station V2 MAI 700 ATO Model
10manufacturers in China registered for this device type
2catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (1), Hebei (1). 2 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 |
| Linxens Healthcare (Tianjin) Co., Ltd. | Jinnan District | Tianjin | Contract manufacturer | 7 |
| 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 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| 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 |
| Shandong Corecare Technology Limited | Jinan | Shandong | Manufacturer | 2 |
Record
| Listed by | GE Medical Systems Information Technologies, Inc., United States |
|---|---|
| FDA product code | DSI |
| Device type | Detector And Alarm, Arrhythmia |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1025 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K162012 |
| Record published | 2017-02-11 |
| Record revised | 2025-04-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 5 to 95 % RH; Storage environment atmospheric pressure 500 to 1075 KiloPascal |
| Distribution end date | 2022-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| V2 Integrated MAI 700 | Withdrawn | |
| V2 Standard MAS 700 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Trulink | Spacelabs Healthcare (Washington), Inc | 160 |
| Fukuda Denshi | Fukuda Denshi Co., Ltd. | 30 |
| Q-Tel RMS | Mortara Instrument, Inc. | 20 |
| Detector And Alarm, Arrhythmia | Philips Medical Systems Hsg | 20 |
| ECG Electrodes | Philips Medical Systems Hsg | 19 |
| Seeq™ | Medtronic, Inc. | 18 |
| Life Sensing Instruments, Inc. | Life Sensing Instruments, Inc. | 17 |
| NIBP Cuffs | Philips Medical Systems Hsg | 14 |
| Waveline EZ+ | Avante | 11 |
| BodyGuardian | Preventice Technologies, Inc. | 10 |
| BodyGuardian Kit | Preventice Technologies, Inc. | 8 |
| Waveline Pro+ | Avante | 7 |
Showing 12 of 112. All products under Detector And Alarm, Arrhythmia
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K062976 | 2007-03-16 |
| K032370 | 2003-08-13 |
Recalls Naming This Product
6 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 Medical Systems Information Technologies, Inc. | 510(k) number | 2026-07-30 | Not classified | Under Investigation by firm | Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events. | 29,570 (23,632 US; 5,938 OUS) | |
| Wipro GE Healthcare Private Ltd. | 510(k) number | 2025-09-05 | Class II | Software design | Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of c | 173 units | |
| Wipro GE Healthcare Private Ltd. | 510(k) number | 2025-09-05 | Class II | Software design | Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of c | 2365 units | |
| GE Medical Systems, LLC | 510(k) number | 2022-05-10 | Class II | Process control | The CARESAPE Central Station (CSCS) V2 can shut down due to a potential power supply component failure. This can lead to loss of patient monitoring at the central station. | 30,993 Central Stations and 2,180 FRUs and displays | |
| GE Medical Systems, LLC | 510(k) number | 2022-01-28 | Class II | Software design | If the CARESCAPE Central Station v2.0 is used with an unapproved keyboard, the audio can be muted resulting in loss of audible alarms. | 10,445 units | |
| GE Medical Systems Information Technologies, Inc. | 510(k) number | 2018-01-11 | Class II | Software in the Use Environment | CARESCAPE Central Station (CSCS) software version 2.0.2 units may experience unexpected NO COMM (No Communication) and network communication issues after boot-up or system restart. | 1803 units | 2021-07-07 |
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 |
|---|---|---|---|---|
| 2025-04-25 | Class II | Software design | The MUSE Administrator Account active directory or local credential could potentially be used from your local network to log into a GE HealthCare MUSE 5 system and potentially manipulate recorded patient data. | 4,277 systems |
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.