FDA Device recall Z-1430-2022
SIGNA Premier magnetic resonance scanner, model 5748519
- FDA Device
- Class II
- ongoing
- Published 2022-07-27
On 2022-07-27 the FDA classified a Class II recall of SIGNA Premier magnetic resonance scanner, model 5748519 by Ge Healthcare, citing under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potenti….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1430-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-06-24 |
| Published | 2022-07-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ge Healthcare |
| Distribution | US |
Product
SIGNA Premier magnetic resonance scanner, model 5748519.
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.
Identifiers
| code_info | SIGNA Premier GTINs: 00840682135269 and 00195278010797 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1430-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.