Reported Sep 3, 2025 · Ongoing
GE HealthCare OEC 9900 Elite C-arm Systems.
GE Medical Systems, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: GE Medical Systems, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- GE HealthCare OEC 9900 Elite C-arm Systems.
- Lot codes and dates
- GTIN00840682114349
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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