GE Medical Systems, LLC 2025-06-18 Health serious FDA
Health · FDA · Recall #FDA-Z-1819-2025
OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital… Recall
Issued June 18, 2025 · GE Medical Systems, LLC
In June 2025, GE Medical Systems, LLC recalled the OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
OEC Elite and OEC 3D Mobile C-Arms Exceeding 4% Source to Image Distance in X-ray Field.
What you should do
- 1 Stop using OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital… 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
- June 18, 2025
- Units affected
- Not reported
- Sold at
- US and OUS
- Recall number
- FDA-Z-1819-2025
- 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.