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U.S. Department of Health and Human Services

Class 2 Device Recall Signa MFO/I Nuclear Magnetic Resonance Imaging System

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 Class 2 Recall
Signa MFO/I Nuclear Magnetic Resonance Imaging System
see related information
Date Posted November 07, 2007
Recall Status1 Terminated on December 11, 2007
Recall Number Z-0170-2008
Recall Event ID 45491
Premarket Notification
510(K) Number
K002611 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product Signa MFO/I Magnetic Resonance System, Model Numbers : 2210339, 2262700, 2276937, 2282853, 2282860, 2282880, 2352129, 2388781, 5105123, 5113339, 2138300-32, 2189500-3, 2198999-4, 2259620-4, 2262700-2, 2269512-2, 2286849-2, 2352129-2, 2377062-5, 2377062-8, Manufactured by GE Hangwei Medical Systems Co., LTD, Beijing PR, China
Code Information Serial Numbers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
Recalling Firm/
Manufacturer
GE Healthcare
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Manufacturer Reason
for Recall
Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Field Modification Instruction : FMI 67631 (DEC 2006) was communicated directly to the GE Healthcare service engineers who provide the modification at the customer site. Corrections were performed in DEC 2006.
Quantity in Commerce 163
Distribution Worldwide Distribution --- USA including states of AL, AR, AZ, CA, CO, CT, FL, ID, IL, IN, KS, KY, LA, MD, MO, MS, MT, NJ, NY, OH, OK, PA, SD, VA, and WA, and countries of United Arab Emirats, Argentina, Belgium, Brazil China, Ivery Cost, Germany, Spain, France, United Kingdom, Hungary, Italy, Japan, Korea, Mexico, Oman, Panama, Puerto Rico, Russia, and Turkey
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
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