GE Healthcare, LLC recalls SIGNA Premier magnetic resonance scanner, model 5748519.
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.
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- GE Healthcare
- Product
- SIGNA Premier magnetic resonance scanner, model 5748519.
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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