CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
GE HealthCare OEC recalled by GE Medical Systems
GE Medical Systems is recalling GE HealthCare OEC 9800, distributed nationwide in the US. The recall was initiated on 2 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2341-2025
- FDA event ID
- 97454
- Recalling firm
- GE Medical Systems, Waukesha, WI
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 2 Jul 2025
- FDA classified
- 22 Aug 2025
- Reported
- 3 Sep 2025
- Type
- FDA Mandated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 2 Jul 2025 | Recall initiated by company | |
| 22 Aug 2025 | Classified by FDA | +51 days |
| 3 Sep 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
GE HealthCare OEC 9800.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
GTIN: 00840682114349
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 97454This product is part of a recall event; the main page for the event is GE HealthCare OEC 9900 Elite C-arm Systems recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | GE HealthCare OEC 9900 Elite C-arm Systems recalled | GE Medical Systems | Other | Nationwide |
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