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Recall Observatory FDA recall evidence

Device product

SIGNA Architect AIR

Z-2131-2025

May 23, 2025

Class II

Product summary

Firm
GE Medical Systems, LLC
Event
Event 97030
Status
Ongoing
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2131-2025

Official wording

Reason: 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 can 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.

Code information: GTIN: 00195278283481

Distribution pattern: Worldwide distribution - US Nationwide and the country of China.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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 can 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.