FDA Medical Device Recalls (openFDA)
GE Medical Systems Information Technologies Inc: 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
- Recall number
- Z-3143-2026
- Recalling firm
- GE Medical Systems Information Technologies Inc
- Product
- 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
- Status
- Open, Classified
- Initiated
- 2026-07-30
- Posted
- 2026-09-11
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 29,570 (23,632 US; 5,938 OUS)
- Distribution
- Worldwide - US Nationwide distribution.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K162012"]
- PMA numbers
- not on file
- Product code
- DQK
- Firm FEI
- 3001570235
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28