Medical device recalls Moderate risk

Wipro GE Healthcare Private Ltd. recalls GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04;…

Recall date
September 5, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0213-2026
FDA classification
Class II
Brand / firm
Wipro GE Healthcare Private Ltd.
Sold / distributed
Worldwide distribution.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube

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