GE HealthCare OEC 9800 recall
GE HealthCare OEC 9800.
Why was GE HealthCare OEC 9800 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 00840682114349
- Product
- GE HealthCare OEC 9800.
- Recalling firm
- GE Medical Systems, LLC
- Distribution
- US Nationwide distribution.
- Recall date
- September 3, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)