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U.S. Department of Health and Human Services

Class 2 Device Recall Signa HDX MR System

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 Class 2 Recall
Signa HDX MR System
see related information
Date Posted September 11, 2008
Recall Status1 Open
Recall Number Z-2225-2008
Recall Event ID 48689
Premarket Notification
510(K) Number
K052293 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE 1.5T and 3.0T Signa HDX MR System Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial sagittula, coronal and oblique images, spectroscopic images, and or spectra, dynamic images of the internal structure or organs of the entire body,
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Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can result in an erroneous diagnosis.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Component Change Control
Action Customer Letter and Operator Manual addendum were sent directly to customers in August 2008. When the software correction is issued, GE Field Engineer will visit each site to implement the correction. (Not conducted yet).
Quantity in Commerce 720 units (360 US / 360 OUS) estimate
Distribution AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS,MT, NC, ND, NE, NJ, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA,WI, and WV. Countries of Argentina Australia Austria Belgium Brazil Canada Chile China Czech Republic Denmark Finland France French Polynesia Germany Greece Hong Kong India Indonesia Ireland Israel Italy Japan Korea Kuwait Lebanon Malaysia Mexico Netherlands New Zealand Norway Peru Philippines Russia Saudi Arabia Singapore South Africa Spain Sweden Switzerland Taiwan Taiwan Thailand Turkey United Arab Emirates 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 MEDICAL SYSTEMS, LLC
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