Recall Z-1430-2022 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
SIGNA Premier magnetic resonance scanner, model 5748519.
| Date | Jun 24, 2022 |
| Status | Open, Classified |
| Reason | 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 | Device Design |
| 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 | 52 |
| Distribution | 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, Sw |
| FDA record | Open on fda.gov |