Z-2341-2025 Class II Ongoing
FDA device recall Z-2341-2025 was initiated by GE Medical Systems, LLC on July 2, 2025 and is designated Class II. 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 i… The recall status is ongoing.
Recall Details
- Product Type
- Devices
- Report Date
- September 3, 2025
- Initiation Date
- July 2, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
Product Description
GE HealthCare OEC 9800.
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.
Distribution Pattern
US Nationwide distribution.
Code Information
GTIN: 00840682114349