GE Medical Systems, LLC 2025-09-03 Health serious FDA
Health · FDA · Recall #FDA-Z-2342-2025
GE HealthCare OEC 9900 Elite C-arm Systems. Recall
Issued September 3, 2025 · GE Medical Systems, LLC
In September 2025, GE Medical Systems, LLC recalled the GE HealthCare OEC 9900 Elite C-arm Systems., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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.
What you should do
- 1 Stop using GE HealthCare OEC 9900 Elite C-arm Systems. right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Medical Systems, LLC to arrange your fda mandated. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (FDA Mandated):
Recall details
- Brand
- GE Medical Systems, LLC
- Category
- Health
- Recall date
- September 3, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide distribution.
- Recall number
- FDA-Z-2342-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- GE Medical Systems, LLC has 12 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.