Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0213-2026 — GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube

U.S. FDA — Device Enforcement · India · 2025-09-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0213-2026
Date of alert
2025-09-05
Country / jurisdiction
India
Risk level
Class II
Risk type
recall
Brand
Wipro GE Healthcare Private Ltd.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00195278343512
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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