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Official recall record

SIGNA™ Architect

Health Canada — Medical Devices · 2024-11-07 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2024-11-07
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

GE Healthcare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels may exceed 99db, the limit established by international electrotechnical commission (IEC 60601-2-33) when using hearing protection with a noise reduction rating (NRR) of 29db, as currently required in the operator manual. Prolonged periods of exposure to elevated acoustic noise could potentially lead to hearing impairment. Recall start date: October 31, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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