Medical Device Recall: GE HealthCare OEC 9800.
GE Medical Systems, LLC · July 2, 2025
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
US Nationwide distribution.
States Affected
NATIONWIDE
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2341-2025
Status: ongoing
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