SIGNA Premier magnetic resonance scanner recall
SIGNA Premier magnetic resonance scanner, model 5748519.
Why was SIGNA Premier magnetic resonance scanner recalled?
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 should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
SIGNA Premier GTINs: 00840682135269 and 00195278010797
- Product
- SIGNA Premier magnetic resonance scanner, model 5748519.
- Recalling firm
- GE Healthcare, LLC
- Quantity
- 52
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, MI, MN, NY, and WI. There was government distribution but no military distribution. The countries of China, France, Hong Kong, India, Italy, Japan, Korea, Kuwait, Norway, Oman, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Thailand, Turkey, and United Kingdom.
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)