GE Healthcare recalls SIGNA Premier MRI scanners (model 5748519) due to rare risk of hearing loss from elevated acoustic noise during scans. Affected units have specific GTINs.
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.
GE Healthcare is recalling SIGNA Premier MRI scanners with model number 57485:19 because rare acoustic noise during scans could cause hearing loss. This recall affects specific units sold with certain product codes.
The gradient coils in SIGNA Premier scanners can produce elevated acoustic noise under rare conditions. Prolonged exposure to this noise may lead to hearing loss over time.
Healthcare facilities using SIGNA Premier MRI scanners with model 5748519 are most affected. Patients undergoing scans with these units may be at risk if exposed to prolonged acoustic noise.
Check for model number 5748519 on the scanner. Affected units have GTINs: 00840682135269 and 00195278010797.
Look for model number 5748519 on the scanner.
The recall indicates a rare risk of hearing loss from prolonged exposure to elevated acoustic noise during scans, but it is not an immediate hazard.
Check for model number 5748519 and GTINs: 00840682135269 or 00195278010797.
The recall does not specify a remedy, so no action is required beyond checking if your unit is affected.
We’ve drafted a message you can send GE Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-1430-2022 — GE Healthcare GE Healthcare Hello, I own a GE Healthcare that is covered by recall Z-1430-2022 from GE Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
