GE Medical Systems, LLC: Device Recall
Recall #Z-2342-2025 · 07/02/2025
Class II: Risk
Recall Details
- Recall Number
- Z-2342-2025
- Classification
- Class II
- Product Type
- Device
- Recalling Firm
- GE Medical Systems, LLC
- Status
- Ongoing
- Date Initiated
- 07/02/2025
- Location
- Waukesha, WI, United States
- Voluntary/Mandated
- FDA Mandated
Reason for Recall
GE HealthCare has become aware of a non-conformance to 21 CFR 1020.30 (k) in certain OEC 9800 and OEC 9900 Elite C-arm Systems. Specifically, impacted systems are missing the full layer of lead tape in the collimator covers, which will lead to a small increase in radiation exposure to the patient and/or operator. The missing lead tape is not detectable by the user.
Product Description
GE HealthCare OEC 9900 Elite C-arm Systems.
Distribution Pattern
US Nationwide distribution.
Other Recalls by GE Medical Systems, LLC
- Class II: Risk 10/24/2025
- Class II: Risk 09/18/2025
- Class II: Risk 09/18/2025
- Class II: Risk 09/18/2025
- Class II: Risk 08/22/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.