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U.S. Department of Health and Human Services

Class 2 Device Recall 1.5T SIGNA HDxt MR System

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  Class 2 Device Recall 1.5T SIGNA HDxt MR System see related information
Date Initiated by Firm August 26, 2021
Date Posted October 16, 2021
Recall Status1 Open3, Classified
Recall Number Z-0141-2022
Recall Event ID 88665
510(K)Number K052293  K121676  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product 1.5T SIGNA HDxt MR System nuclear magnetic resonance imaging system
Code Information Software version HD29.1; and HD16.2 (China only)
Recalling Firm/
Manufacturer		 GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
800-437-1171
Manufacturer Reason
for Recall		 Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
FDA Determined
Cause 2		 Software design
Action GE issued an Urgent Medical Device Correction letter to customers with affected devices. This letter informs the customer of the issue and provides safety instructions for the continued use of the device. GE Healthcare will correct all affected devices at no cost to the customer. In the U.S., this letter will be sent by a traceable means. This letter will be sent to the following titles within the affected accounts: Director of Clinical/Radiology, Risk Manager/Hospital Administrator.
Quantity in Commerce 3 devices
Distribution Distribution in United States to AZ, CA, FL, GA, IL, LA, MA, MD, MN, NC, NH, NJ, NY, OH, OK, TX, VA, WA, and Puerto Rico OUS distribution to: Australia, Belgium, Canada, Chile, Colombia, France, Germany, Italy, Japan, Korea, Poland, Saudi Arabia, Spain, Sweden, Turkey, UAE, and UK
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 and Original Applicant = GE MEDICAL SYSTEMS, LLC
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