GE Healthcare…

Date posted by the FDA

Oct. 26, 2011

Status

Terminated

Filed by

GE Healthcare, LLC

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.

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.

Distribution pattern

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

Quantity

52

Codes and lots

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

Recall started

Aug. 29, 2011

Device type

System, Nuclear Magnetic Resonance Imaging

Root cause (FDA)

Nonconforming Material/Component

What the company told customers

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.

Recall number

Z-0107-2012

What should I do? How serious is a recall? Classes and warnings explained

Source: FDA · Medical device enforcement report, recall number Z-0107-2012. The agency record governs; check it and the company before acting.