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 Part Number 5867474-03 P

Is my product affected?

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

• UPC 00195278343512
• UPC 00195278516367
• UPC 00195278343383

Check against the official notice below — it lists the full affected range.

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.

Details from the source

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: Worldwide - US Nationwide distribution. Quantity: 29,570 (23,632 US; 5,938 OUS) Lot/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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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