FDA-Device2025-10-29Class II

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube

Wipro GE Healthcare Private Ltd.
Hazard

GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

Sold states
Worldwide distribution.
Affected count
2306 units
Manufactured in
122 Part 1, Odyssey And Galileo, Bengaluru, India
Products
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0214-2026

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