GE Healthcare, LLC SIGNA Premier magnetic resonance scanner, model 5748519. Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SIGNA Premier magnetic resonance scanner, model 5748519.
Brand
GE Healthcare, LLC
Lot Codes / Batch Numbers
SIGNA Premier GTINs: 00840682135269 and 00195278010797
Products Sold
SIGNA Premier GTINs: 00840682135269 and 00195278010797
GE Healthcare, LLC is recalling SIGNA Premier magnetic resonance scanner, model 5748519. due to Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acou. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The recalling firm issued letters dated 6/24/2022 via traceable means on 6/24/2022. The letter explained the safety issue, affected product details, and actions to be taken by the customer/user. The consignee is informed they can continue to use the device but ensure hearing protection with a Noise Reduction Rating (NRR) of at least 33dB is used during exams on these systems. The firm provided an Operator Manual addendum for the impacted devices to require the use of hearing protection with a Noise Reduction Rating (NRR) of 33dB. To assist with the transition, the firm provided an initial quantity of 200 pairs of disposable ear protection with an NRR of 33dB. A response form was enclosed for completion and return no later than 30 days from receipt to confirm receipt and understanding of the notice.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026