SIGNA Architect AIR
Reported: July 30, 2025 Initiated: May 23, 2025 #Z-2131-2025
Product Description
SIGNA Architect AIR
Reason for Recall
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.
Details
- Recalling Firm
- GE Medical Systems, LLC
- Units Affected
- N/A
- Distribution
- Worldwide distribution - US Nationwide and the country of China.
- Location
- Waukesha, WI
Frequently Asked Questions
What product was recalled? ▼
SIGNA Architect AIR. Recalled by GE Medical Systems, LLC. Units affected: N/A.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 30, 2025. Severity: Moderate. Recall number: Z-2131-2025.
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