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3 catalysts · 16,306 approval · 2,546 device 510k · 485 recall · 277 device pma · 3 device recall
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3 catalysts · 16,306 approval · 2,546 device 510k · 485 recall · 277 device pma · 3 device recall
GE HealthCare OEC 9900 Elite C-arm Systems. — Reason: 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. — Status: Ongoing
GE HealthCare OEC 9800. — Reason: 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. — Status: Ongoing
Sparrow Ascent Patient Controller, REF's: 11-110-K, 11-310-K, 11-320-K, 11-321-K, 11-310-K-28, 11-320-K-28, 11-321-K-28 — Reason: Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. — Status: Ongoing