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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 Posted April 11, 2013
Recall Status1 Terminated 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


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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LNH and Original Applicant = GE HEALTHCARE JAPAN CORPORATION
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