Recall Z-0213-2026 ยท DXJ Display, Cathode-Ray Tube, Medical
Wipro GE Healthcare Private Ltd.
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
| Date | Oct 21, 2025 (initiated Sep 5, 2025) |
| Status | Open, Classified |
| Reason | Carescape Central Station (CSCS), software version V3.0.5, 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. |
| Root cause | Software design |
| 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 compl |
| Quantity | 173 units |
| Distribution | Worldwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162012 | CARESCAPE Central Station V2 GE Healthcare, Sep 15, 2016 |