GE Medical Systems Information Technologies Inc: Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Pa
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- GE Medical Systems Information Technologies Inc
- 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 / hazard
- 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.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- Worldwide - US Nationwide distribution.
- Recall initiated
- 2026-07-30
- 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
- Product quantity
- 29,570 (23,632 US; 5,938 OUS)
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Waukesha
- State
- WI
- Country
- United States
- Event id
- 99637
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