—#194950

Product

SIGNA Premier magnetic resonance scanner, model 5748519.

FDA product code: LNH — System, Nuclear Magnetic Resonance Imaging
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K171128, K183231, K193282
Affected lot / code info: SIGNA Premier GTINs: 00840682135269 and 00195278010797

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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.

Timeline

Recall initiated: 2022-06-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194950. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.