FDA Medical Device Recalls (openFDA)
GE Healthcare, LLC: SIGNA Premier magnetic resonance scanner, model 5748519.
- Recall number
- Z-1430-2022
- Recalling firm
- GE Healthcare, LLC
- Product
- SIGNA Premier magnetic resonance scanner, model 5748519.
- Status
- Open, Classified
- Initiated
- 2022-06-24
- Posted
- not on file
- Terminated
- not on file
- 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 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.
- 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, Switzerland, Thailand, Turkey, and United Kingdom.
- Lot, serial or model codes
- SIGNA Premier GTINs: 00840682135269 and 00195278010797
- 510(k) numbers
- ["K171128","K183231","K193282"]
- PMA numbers
- not on file
- Product code
- LNH
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28