FDA Medical devices recall ·
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04… recall
- Recall number
- Z-3143-2026
- Date
- (initiated July 30, 2026)
- Company / brand
- GE Medical Systems Information Technologies Inc
3114 N Grandview Blvd, Waukesha, WI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 29,570 (23,632 US; 5,938 OUS)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot 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
Distribution
Worldwide - US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3143-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.