Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1430-2022 — SIGNA Premier magnetic resonance scanner, model 5748519.

U.S. FDA — Device Enforcement · United States · 2022-06-24 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1430-2022
Date of alert
2022-06-24
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
GE Healthcare, LLC
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00840682135269
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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