Recall Z-2341-2025— GE Medical Systems, LLC
Class II · Ongoing
Class II FDA medical device recall by GE Medical Systems, LLC, initiated 2025-07-02. It names 3 FDA 510(k) clearances: K132027, K111551, K021049. Product: 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..
- 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
3 on FDA's record- K132027 — OEC 9800 PLUS
- K111551 — OEC(R) 9800, OEC(R) 9800 PLUS
- K021049 — OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM
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 9800.
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.