GE Healthcare, LLC 2022-04-13 Health serious FDA
Health · FDA · Recall #FDA-Z-0857-2022
Signa 1.5T TwinSpeed Magnetic Resonance Imaging System Recall
Issued April 13, 2022 · GE Healthcare, LLC
In April 2022, GE Healthcare, LLC recalled the Signa 1.5T TwinSpeed Magnetic Resonance Imaging System, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
There is potential for the images to be flipped left to right.
What you should do
- 1 Stop using Signa 1.5T TwinSpeed Magnetic Resonance Imaging System right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact GE Healthcare, 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 Healthcare, LLC
- Category
- Health
- Recall date
- April 13, 2022
- Units affected
- Not reported
- Sold at
- Worldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan, Bosnia and Herzegovina, Brazil, Canada, China, Denmark, Ecuador,
- Recall number
- FDA-Z-0857-2022
- Made in
- United States
- Issuing agency
- FDA
In context
- GE Healthcare, LLC has 14 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.