- Recalling firm
- GE Medical Systems Information Technologies Inc
- Reason for recall
- 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.
- Affected products (lot / model / serial)
- 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
- Units affected
- 29,570 (23,632 US; 5,938 OUS)
- Distribution pattern
- Worldwide - US Nationwide distribution.
- Firm location
- Waukesha, WI, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-3143-2026
- Recall initiated
- July 30, 2026
- FDA classification date
- September 11, 2026
- FDA report date
- September 23, 2026
- FDA event ID
- 99637
- Last updated on HTM Vibe
- September 29, 2026