Recall Z-2342-2025— GE Medical Systems, LLC

Name: FDA recall Z-2342-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-02

Class II · Ongoing

Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-07-02. It names 4 FDA 510(k) clearances: K122234, K120613, K082781 and 1 more. Product: 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..

Recalling firm: GE Medical Systems, LLC
Classification: Class II
Status: Ongoing
Initiated: 2025-07-02
Firm location: Waukesha, WI, United States

510(k) clearances named in this recall

4 on FDA's record

K122234 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2012-08-16
K120613 — OEC 9900 ELITEGe Healthcare Surgery GE Oec Medical Systems, Inc.·cleared 2012-04-06
K082781 — OEC 9900 ELITEGe Healthcare Surgery·cleared 2009-05-01
K073543 — OEC 9900 ELITEGe Oec Medical Systems·cleared 2008-05-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

GE HealthCare OEC 9900 Elite C-arm Systems.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.