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U.S. Department of Health and Human Services

Class 2 Device Recall GE Healthcare, MSK 1.5T Extreme MR Scanner Model AA5000

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 Class 2 Recall
GE Healthcare, MSK 1.5T Extreme MR Scanner Model AA5000
see related information
Date Posted October 26, 2011
Recall Status1 Terminated on May 29, 2012
Recall Number Z-0107-2012
Recall Event ID 59522
Premarket Notification
510(K) Number
K080048 
Product Classification System, Nuclear Magnetic Resonance Imaging - Product Code LNH
Product GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000. The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of the internal structures of the leg (excluding the thigh), knee, ankle, foot, forearm, elbow, wrist and hand.
Code Information 06012008-001 12182008-001 12162008-001 03132009-001 03242009-001 05152009-001 07142009-001 08082009-001 09172009-001 12072009-001 10252009-001 01082010-001 012720100-001 03072010-001 03252010-001 04012010-001 05262010-001 06082010-001 06182010-001 09142010-001 11292010-001 10182010-001 12052010-001 08122009-001 09222009-001 02242010-001 10082009-001 02112010-001 10222010-001 08132009-001 12222010-001 06192009-001 10312010-001 10142009-001 09222010-001 10012009-001 06042009-001 06062009-001 09072009-001 01182010-001 03012010-001 07272010-001 09132010-001 10082010-001 11162010-001 12152009-001 12242009-001 12142009-001 04302010-001 04082010-001 05072010-001 08152010-001
Recalling Firm/
Manufacturer
GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
GE Healthcare has recently become aware that an exposed high voltage gradient wire internal to the MSK 1.5T Extreme system equipment may cause electrical shock, which may impact service personnel safety. This issue does not impact patient or operator safety.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action GE Healthcare LLC sent a "Urgent Medical Device Correction letter" dated August 29, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The customer was instructed to please ensure that all potential service personnel at your facility are made aware of this safety notification and the recommended actions. Contact your local service representative if you have any questions concerning this notification. For further questions please call ( 262 ) 513-4122.
Quantity in Commerce 52
Distribution Worldwide Distribution -- USA (nationwide) including the states of AL, CA, FL, ID, NY, NH, NJ, NV, OH, PA, TX, VA and WI., and countries of UNITED ARAB EMIRATES, UKRAINE, UNITED KINGDOM, SWITZERLAND
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 = ONI MEDICAL SYSTEMS, INC.
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