GE Healthcare, LLC 2022-07-27 Health serious FDA
Health · FDA · Recall #FDA-Z-1430-2022
SIGNA Premier magnetic resonance scanner, model 5748519. Recall
Issued July 27, 2022 · GE Healthcare, LLC
In July 2022, GE Healthcare, LLC recalled the SIGNA Premier magnetic resonance scanner, model 5748519., a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
What you should do
- 1 Stop using SIGNA Premier magnetic resonance scanner, model 5748519. 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
- July 27, 2022
- Units affected
- Not reported
- Sold at
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but
- Recall number
- FDA-Z-1430-2022
- 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.