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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare Signa Architect

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 Class 2 Device Recall GE Healthcare Signa Architectsee related information
Date Initiated by FirmMay 23, 2025
Date PostedJuly 18, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2133-2025
Recall Event ID 97030
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductSIGNA PET/MR
Code Information GTIN: 00840682105378
FEI Number 2183553
Recalling Firm/
Manufacturer		 GE Medical Systems, LLC
3200 N Grandview Blvd
Waukesha WI 53188-1693
For Additional Information ContactGE HealthCare Service
800-437-1171
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionGE Healthcare issued an URGENT MEDICAL DEVICE CORRECTION to its consignees on 05/23/2025 delivered using traceable means. The notice explained the issue, risk, and requested the following: Actions to be taken by Customer/User: You can continue to use your MR system by following the instructions below: Ensure hearing protection with a Noise Reduction Rating (NRR) of at least 33dB is used during exams on these systems. 200 pairs are provided with this letter. Please post this letter in your facility on or near the MR operator console. Please ensure all potential users in your facility are made aware of this safety notification and the recommended actions. Please retain this document for your records. Please complete and return the attached acknowledgement form to recall.60999@gehealthcare.com.
DistributionWorldwide distribution - US Nationwide and the country of China.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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