Recall Z-0214-2026
Wipro GE Healthcare Private Ltd. · initiated September 5, 2025
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: GTIN 00195278343383, Serial Numbers: STV25225456SA, STV25225455SA, STV25266464SA, STV25235817SA, STV25235816SA, STV25286682SA, STV25225594SA, STV25235792SA, STV25235774SA, STV25225550SA, STV25235626SA, STV25235625SA, STV25184592SA, STV25235628SA, STV25235631SA, STV25184595SA, STV25235629SA, STV25235632SA, STV25235630SA, STV25276515SA, STV25225510SA, STV25276516SA, STV25225505SA, STV25225508SA, STV25225509SA, STV25225507SA, STV25225506SA, STV25113369SA, STV25204986SA, STV25205160SA, STV25205151SA, STV25205161SA, STV25062736SA, STV25256133SA, STV25225512SA, STV25296702SA, STV25296701SA, STV25296748SA, STV25256214SA, STV25225511SA, STV25256215SA, STV25256199SA, STV25256216SA, STV25256202SA, STV25225497SA, STV25225514SA, STV25225498SA, STV25256131SA, STV25256129SA, STV25256128SA, STV25296747SA, STV25256132SA, STV25256362SA, STV25225494SA, STV25225513SA, STV25296697SA, STV25256153SA, STV25296745SA, STV25256130SA, STV25256134SA, STV25256198SA, STV25296749SA, STV25296698SA, STV25256112SA, STV25256111SA, STV25225495SA, STV25256127SA, STV25256197SA, STV25296700SA, STV25296699SA, STV23440159SA, STV23440160SA, STV23440161SA, STV23440162SA, STV23440163SA, STV23440164SA, STV23440165SA…
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-0214-2026
- Initiated
- September 5, 2025
- Posted by FDA
- October 21, 2025
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Quantity
- 2365 units
- Distribution
- Worldwide distribution.
- Recalling firm
- Wipro GE Healthcare Private Ltd., Bengaluru
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0213-2026 Class II | GE Healthcare Carescape Central Station (CSCS) V3 MAS800 Desktop with software version…Carescape Central Station (CSCS), software version V3.0.5, can cause the system to enter a continuous reboot… | 09/05/2025Open, Classified |