FDAFDA recall Z-3143-2026 · Sep 23, 2026
GE Medical Systems Information Technologies Inc: Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04 recall
Recall found
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
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- 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
- Quantity
- 29,570 (23,632 US; 5,938 OUS)
- Distribution
- Worldwide - US Nationwide distribution.
- Recalling firm
- GE Medical Systems Information Technologies Inc, Waukesha, WI
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-30
Source: openFDA enforcement record Z-3143-2026 · search recall number Z-3143-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.