Recall Z-3143-2026 ยท DQK Computer, Diagnostic, Programmable
GE Medical Systems Information Technologies Inc
Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 Product code STU CSCS V3 MAI800 Integrated Part Number 5867474-03 Product Code STV
| Date | Sep 11, 2026 (initiated Jul 30, 2026) |
| Status | Open, Classified |
| Reason | Device may not resume patient monitoring for at least 3 minutes following system restart. Issue can lead to potential delay in recognition of clinically significant events. |
| Root cause | Under Investigation by firm |
| Action | On July 30, 2026, the firm sent Urgent Medical Device Correction letters to customers with affected units. This letter informs the customer of the issue and provides actions to be taken by the customer/user for continued use of the device. GE HealthCare will provide a User Manual Addendum that provides guidance regarding the prolonged startup condition. |
| Quantity | 29,570 (23,632 US; 5,938 OUS) |
| Distribution | Worldwide - US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162012 | CARESCAPE Central Station V2 GE Healthcare, Sep 15, 2016 |