SIGNA Premier magnetic resonance scanner, model 5748519.
FDA Recall Z-1430-2022 · Posted None
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Recalling FirmGE Healthcare, LLC
Recall StatusOpen, Classified
Product CodeLNH
Date Initiated2022-06-24
Product Quantity52
Reason for Recall
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.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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