GE Healthcare, LLC 2022-02-16 Health serious FDA
Health · FDA · Recall #FDA-Z-0600-2022
GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist… Recall
Issued February 16, 2022 · GE Healthcare, LLC
In February 2022, GE Healthcare, LLC recalled the GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
What you should do
- 1 Stop using GE Healthcare MR superconducting magnets, a component of GE Healthcare SIGNA Artist… 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
- February 16, 2022
- Units affected
- Not reported
- Sold at
- Distribution was nationwide, including Puerto Rico and the Virgin Islands. There was also government and military distribution. Foreign di
- Recall number
- FDA-Z-0600-2022
- 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.