Class 2 Device Recall GE Healthcare

• Date Initiated by Firm: October 28, 2024
• Date Posted: November 22, 2024
• Recall Status: Open, Classified
• Recall Number: Z-0520-2025
• Recall Event ID: 95735
• 510(K)Number: K142098 K163619 K213709
• Product Classification: System, nuclear magnetic resonance imaging - Product Code LNH
• Product: Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVERY PET/MR,
• Code Information: 1) UDI/DI To be provided, System ID 82427070262; 2) UDI/DI To be provided, System ID EX0133
• FEI Number: 2183553
• Recalling Firm/ Manufacturer: GE Medical Systems, LLC; 3200 N Grandview Blvd; Waukesha WI 53188-1693
• For Additional Information Contact: GE HealthCare Service; 800-437-1171
• Manufacturer Reason for Recall: Gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning.
• FDA Determined Cause: Device Design
• Action: GE Healthcare issued an "URGENT MEDICAL DEVICE CORRECTION" notice to its consignees on 10/28/20224 delivered through a traceable means. The notice explained the issue, safety issue, and requested the following actions be taken for the continued safe usage of the affected devices: "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.60998@gehealthcare.com. For questions or concerns, please contact GE HealthCare Service at 1-800-437-1171 or your local Service Representative.
• Quantity in Commerce: 2 units
• Distribution: Worldwide Distribution: US (nationwide) and OUS (foreign) to countries of: Canada, China, India, Japan, Korea, Latvia, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.
• Total Product Life Cycle: TPLC 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.

• 510(K) Database: 510(K)s with Product Code = LNH