| ||Class 2 Recall|
GE Healthcare, MSK 1.5T Extreme MR Scanner Model AA5000
||October 26, 2011
||Terminated on May 29, 2012
|Recall Event ID
System, Nuclear Magnetic Resonance Imaging - Product Code LNH
||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.
|GE Healthcare, LLC
3000 N Grandview Blvd
Waukesha, Wisconsin 53188-1615
||Contact the recalling firm for information
|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.
|COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
||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
||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)s with Product Code = LNH and Original Applicant = ONI MEDICAL SYSTEMS, INC.