Oec 9900 Elite

510(k) K082781

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK082781	Date1 May 2009Cleared	StatusActive

4 recalls · 3 ongoing · FDA

- Ongoing Z-2342-2025 FDA Class II initiated 2 Jul 2025
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.
- Ongoing Z-0705-2025 FDA Class II initiated 21 Nov 2024 on shared 510(k) K082781
Due to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability.
- Ongoing Z-2277-2023 FDA Class II initiated 15 May 2023 on shared 510(k) K082781
Image intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force when moved, which may result in the image intensifier falling, which could lead to injuries such as fractures, hematoma, contusion, bruise, pain.
- Terminated Z-1462-2014 FDA Class II initiated 31 Mar 2014
GE Healthcare has identified a potential safety issue related to the screws that attach the workstation monitor spring arm to the extension arm on certain OEC 9900 systems, causing the spring arm and monitor to fall forward.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

1 jurisdiction

United States — FDA 510(k) Active

510(k)