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U.S. Department of Health and Human Services

Class 2 Device Recall Optima MR450w 1.5T

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 Class 2 Device Recall Optima MR450w 1.5Tsee related information
Date Initiated by FirmSeptember 08, 2020
Create DateOctober 20, 2020
Recall Status1 Terminated 3 on April 28, 2021
Recall NumberZ-0128-2021
Recall Event ID 86452
510(K)NumberK091536 K163331 
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
ProductSystem, Nuclear Magnetic Resonance Imaging - Product Usage: is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times.
Code Information Model: 5741000-23 and 5396469  
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information ContactStephanie Cass
262-312-7277
Manufacturer Reason
for Recall		Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
FDA Determined
Cause 2		Process change control
ActionOn 09/08/20 the firm sent a Customer Letter to its consignees with the following instructions: You can continue to use the system. In the event the PGR cabinet needs to be serviced, power down the PGR at the Main Disconnect Panel (MDP) then follow MDP Lockout/Tagout from the current released service methods and documentation. GE Healthcare will correct all affected products at no cost to you. A GE Healthcare representative will contact you to arrange for the correction
Quantity in Commerce30 devices total
DistributionWorldwide distribution - US Nationwide distribution including in the states of FL, KY, NC, NJ, NM, NY, TX, UT and WA. The countries of Canada, Hungary, India, Korea, China, Russia, Taiwan, Puerto Rico and Ubekistan.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LNH
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