Recall Z-0107-2012 ยท LNH System, Nuclear Magnetic Resonance Imaging
GE Healthcare, LLC
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.
| Date | Oct 26, 2011 (initiated Aug 29, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080048 | MSK EXTREME MR SCANNER, MODEL AA5000 Oni Medical Systems, Inc., Feb 6, 2008 |