Recall Z-0214-2026— Wipro GE Healthcare Private Ltd.

Name: FDA recall Z-0214-2026
Creator: U.S. Food and Drug Administration
Published: 2025-09-05

Class II · Ongoing

Class II FDA medical device recall by Wipro GE Healthcare Private Ltd., initiated 2025-09-05. It names one FDA 510(k) clearance: K162012. Product: GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5, Part Number 5867474-03; Medical Display, cathode ray tube. Reason: 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..

Recalling firm: Wipro GE Healthcare Private Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2025-09-05
Firm location: Bengaluru, India

510(k) clearances named in this recall

1 on FDA's record

K162012 — CARESCAPE Central Station V2GE Healthcare·cleared 2016-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.