CARESCAPE Central Station recallZ-3143-2026 · GE Medical Systems Information Technologies Inc · initiated Jul 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from GE Medical Systems Information Technologies Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On July 30, 2026, the firm sent Urgent Medical Device Correction letters to customers with affected units. This letter informs the customer of the issue and provides actions to be taken by the customer/user for continued use of the device. GE HealthCare will provide a User Manual Addendum that provides guidance regarding the prolonged startup condition.
Recall details
- Recall number
- Z-3143-2026
- Status
- Open, Classified
- Initiated by the company
- Jul 30, 2026
- Posted by the FDA
- Sep 11, 2026
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Quantity
- 29,570 (23,632 US; 5,938 OUS)
- Product code
- DQK
- FDA submissions
- K162012
- Distribution
- Worldwide - US Nationwide distribution.
Product description
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
Code information (models, lots, serial numbers)
5867474-04 UDI-DI 00195278343512 Device Serial Numbers begin with STU 5867474-13 UDI-DI 00195278516367 Device Serial Numbers begin with STU 5867474-03 UDI-DI 00195278343383 Device Serial Numbers begin with STV
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- CARESCAPE CENTRAL STATION MAI800Ge Medical Systems Information Technologies, Inc. · Computer, Diagnostic, Programmable3 recalls0 reports
- CARESCAPE CENTRAL STATION MAI800Ge Medical Systems Information Technologies, Inc. · Computer, Diagnostic, Programmable2 recalls1 death1 report
Product lines
Other devices under the same FDA submission
2 devices cleared under K162012 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- CARESCAPE Central Station V2 Standard MAS 700Ge Medical Systems Information Technologies, Inc. · DETECTOR AND ALARM, ARRHYTHMIA3 recalls0 reports
- CARESCAPE Central Station V2 Integrated MAI 700Ge Medical Systems Information Technologies, Inc. · DETECTOR AND ALARM, ARRHYTHMIA3 recalls0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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