FDA Device recall Z-2341-2025
GE HealthCare OEC 9800
- FDA Device
- Class II
- ongoing
- Published 2025-09-03
On 2025-09-03 the FDA classified a Class II recall of GE HealthCare OEC 9800 by Ge Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2341-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-02 |
| Published | 2025-09-03 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ge Medical Systems |
| Distribution | US |
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.
Identifiers
| code_info | GTIN: 00840682114349 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2341-2025%22
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