Official recall notice
FDA DeviceClass IINotable
FDA Recall: Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product cod
- Recall date
- 2026-09-23
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
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.
Product description
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.
Affected products
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