GE Medical Systems, LLC recalls GE HealthCare OEC 9800.
- Recall date
- July 2, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2341-2025
- FDA classification
- Class II
- Brand / firm
- GE Medical Systems, LLC
- Sold / distributed
- US Nationwide distribution.
Why it was 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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
GE HealthCare OEC 9800.
Get recall alerts
Free email alert whenever GE Medical Systems, LLC has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: GE Medical Systems, LLC