Z-3143-2026 Class II Ongoing
FDA device recall Z-3143-2026 was initiated by GE Medical Systems Information Technologies Inc on July 30, 2026 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 29,570 (23,632 US; 5,938 OUS).
Recall Details
- Product Type
- Devices
- Report Date
- September 23, 2026
- Initiation Date
- July 30, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29,570 (23,632 US; 5,938 OUS)
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
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.
Distribution Pattern
Worldwide - US Nationwide distribution.
Code Information
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