Class 2 Device Recall Signa HDX MR System

• Date Initiated by Firm: March 28, 2008
• Date Posted: September 11, 2008
• Recall Status: Terminated on December 17, 2011
• Recall Number: Z-2225-2008
• Recall Event ID: 48689
• 510(K)Number: K052293
• Product Classification: Magnetic Resonance Scanner - 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 WI 53188-1615
• For Additional Information Contact: 262-544-3894
• 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: Software 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 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 MEDICAL SYSTEMS, LLC