GE Medical Systems, LLC 2025-01-15 Health serious FDA
Health · FDA · Recall #FDA-Z-0812-2025
GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1)… Recall
Issued January 15, 2025 · GE Medical Systems, LLC
In January 2025, GE Medical Systems, LLC recalled the GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1)…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement performed, some bolts used in the Column Safety mechanism can be missing. If these bolts are missing and a failure of the internal counterpoise cable occurs, the Column Safety mechanism will not work properly causing the arm with X-ray tube and collimator to drop downward on the column track.
What you should do
- 1 Stop using GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1)… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Medical Systems, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- GE Medical Systems, LLC
- Category
- Health
- Recall date
- January 15, 2025
- Units affected
- Not reported
- Sold at
- Worldwide
- Recall number
- FDA-Z-0812-2025
- 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.