FDA Recall Open, Classified

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

Recall: Z-0214-2026 · Initiated September 5, 2025

Recall

Recall Number
Z-0214-2026
Event Number
97646
Firm
Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India
FEI Number
3007734888
Product Code
DXJ
Status
Open, Classified
Root Cause
Software design
Initiated
September 5, 2025
Posted
October 21, 2025

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

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.

Action

GE HealthCare issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 09/05/2025, by letter delivered via traceable means. The notice explained the issues and requested the following: "Actions to be taken by Customer/User Pending correction by GE HealthCare, you can continue to use your device by following the instructions below. 1. Determine the number of central stations that are connected to the network including those in any offsite Central Monitoring Unit. 2. Ensure the number of connected central stations are fewer than 118 or more than 120. If you need assistance completing steps 1 or 2, please contact GE HealthCare Service or your local Service Representative. Note: Any versions prior to CSCS V3.0.5 are not affected by this issue. Ensure all users are aware of, understand, and follow these instructions. Please retain this document for your records. GE HealthCare will correct all affected products at no cost to you. A GE HealthCare representative will contact you to arrange for the correction. If you have any questions or concerns regarding this notification, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.

Distribution

Worldwide distribution.

Quantity

2306 units