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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare

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 Class 2 Device Recall GE Healthcaresee related information
Date Initiated by FirmOctober 28, 2024
Date PostedNovember 22, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0517-2025
Recall Event ID 95735
510(K)NumberK142085 K160618 K163331 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductDiscovery MR750w 3.0T, whole body magnetic resonance scanner
Code Information System ID 760724DVMR1, UDI/DI To be provided; System ID 214820TS750WMR, UDI/DI To be provided; System ID 281333MR2, UDI/DI To be provided; System ID 82427240081, UDI/DI (01)00840682103817(11)181200(21)PG75W1800047SC; System ID 82427120136, UDI/DI Not Applicable; System ID 82427200092, UDI/DI To be provided; System ID 82427250061, UDI/DI To be provided; System ID EM0232, UDI/DI Not Applicable
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		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 2		Device Design
ActionGE 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 Commerce8 units
DistributionWorldwide 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 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.
510(K) Database510(K)s with Product Code = LNH
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