GE HealthCare is recalling certain OEC 9800 and OEC 9900 Elite C-arm imaging systems because they are missing a necessary layer of lead tape in the collimator covers. This defect is a manufacturing non-conformance that is not visible to the operator and leads to increased radiation exposure. Healthcare providers and hospital staff should stop using the affected imaging systems and contact the manufacturer to arrange for a correction.
The missing lead shielding results in a small increase in radiation exposure to both the patient and the equipment operator. This non-conformance violates federal radiation safety standards (21 CFR 1020.30) and increases the long-term cumulative radiation risk for clinical staff and patients.
Recall number Z-2341-2025
Recall number Z-2342-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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