GE Healthcare Carescape Central Station — Class II medical device recall Z-0213-2026
Ongoing recall by Wipro GE Healthcare Private Ltd., reported 2025-10-29. Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot c
| Recall number | Z-0213-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wipro GE Healthcare Private Ltd., Bengaluru, India |
| Recall initiated | 2025-09-05 |
| Classified | 2025-10-21 |
| Reported by FDA | 2025-10-29 |
| Quantity | 173 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00195278343512 |
| Serial numbers | STU23160011SA, STU23240007SA, STU23240015SA, STU24200003SA, STU24200004SA, STU24200005SA, STU24200006SA, STU24200007SA, STU24240005SA, STU24240007SA, STU24240008SA, STU24240012SA, STU24240013SA, STU24240014SA, STU24240019SA, STU24240020SA, STU24240021SA, STU24240022SA, STU24310001SA, STU24330016SA, STU24330017SA, STU24330018SA, STU24330019SA, STU24330020SA, STU24330021SA and 148 more |
| Model numbers | 5867474-04 |
Product
GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version V3.0.5; Part Number 5867474-04; Medical Display, cathode ray tube
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0213-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.