Device recall

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

FDA recall source

Recall number

Z-3143-2026

Event id

99637

Status

Ongoing

FDA classification

Class II

Recalling firm

GE Medical Systems Information Technologies Inc

Report date

Sep 23, 2026

Posted

Sep 11, 2026

Initiated

Jul 30, 2026

Center classification date

Sep 11, 2026

Product code

DQK

Device type

Computer, Diagnostic, Programmable

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

Quantity

29,570 (23,632 US; 5,938 OUS)

Code info

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

Distribution

Worldwide - US Nationwide distribution.

Voluntary or mandated

Voluntary: Firm initiated

Related 510(k)s

K162012

Location

Waukesha, WI, United States