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
FDA Recall Z-0170-2008 · Posted 2007-11-07
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Recalling FirmGE Healthcare
Recall StatusTerminated
Product CodeLNH
Date Initiated2006-12-31
Date Terminated2007-12-11
Product Quantity163
Reason for Recall
Incorrect patient positioning; when moving the patient into the bore may lead to wrist and hand injury.
Firm 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
Root Cause
Labeling design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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