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U.S. Department of Health and Human Services

Class 2 Device Recall Discovery MR750w 3.0T System

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  Class 2 Device Recall Discovery MR750w 3.0T System see related information
Date Initiated by Firm April 23, 2012
Date Posting Updated April 11, 2013
Recall Status1 Terminated 3 on March 14, 2014
Recall Number Z-1100-2013
Recall Event ID 64763
510(K)Number K103327  
Product Classification System, nuclear magnetic resonance imaging - Product Code LNH
Product GE Healthcare, Discovery MR750w 3.0T System.
Part Number: 5352293.

Product Usage: It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra,dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate,blood vessels, and musculoskeletal regions of the body.
Code Information Serial Number, 00000000UA0027, 00000000UA0012, 00000000UA0029, 00000000UA0031, 00000000UA0030, 00000000UA0028, 00000000UA0034, 00000000UA0038, 00000000UA0048, 00000000UA0046, 00000000UA0052, 00000000UA0041, 00000000UA0011A, 00000000UA0055, 00000000UA0056, 00000000UA0057, 00000000UA0064, 00000000UA0053, 00000000UA0044, 00000000UA0047, 00000000UA0010, 00000000UA0013, 00000000UA0017, 00000000UA0042, 00000000UA0016, 00000000UA0019, 00000000UA0015, 00000000UA0058, 00000000UA0051, 00000000UA0025, 00000000UA0024, 00000000UA0020, 00000000UA0040, 00000000UA0018, 00000000UA0036, 00000000UA0043, 00000000UA0054, 00000000UA0022, 00000000UA0023, 00000000UA0045, 00000000UA0039, 00000000UA0035, 00000000UA0049, 00000000UA0021, 00000000UA0033, 00000000UA0037

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Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-513-4122
Manufacturer Reason
for Recall
GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in frequency encoding direction (including S/I, A/P and R/L) can result in incorrect localization of anatomy and pathological findings.
FDA Determined
Cause 2
Software design
Action GE Healthcare sent an Important Product Information letter dated April 23, 2012. The letter described the Issue, Instructions, Affected Product Details and Product Correction. For questions contact your local service representative.
Quantity in Commerce 46
Distribution Worldwide Distribution - USA (nationwide) including the states of: AZ, CA, CO, FL, IL, MD, NJ, NY, OH, OK, TX. and the countries of Australia, Belarus, Canada, France, Germany, India, Japan, Lebanon, New Zealand, Saudi Arabia, Singapore, Spain, Sweden, Switzerland and United Kingdom.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE HEALTHCARE JAPAN CORPORATION
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