MSK EXTREME MR SCANNER, MODEL AA5000 The 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.

Recall details

Manufacturer

GE Healthcare, LLC

Distributor

Worldwide Distribution - USA including AL, CA, CO, FL, ID, IL, MA, NH, NJ, NY, OH, PA, SC, SD, TN, TX, UT, VA, WA, WI; Worldwide: Argentina, Australia, Austria, Brazil, Canada, Chile, Denmark, Egypt, Finland, Germany, India, Italy, Japan, Korea, Malaysia, Netherlands, Norway, Peru, Poland, Russia, Singapore, South Africa, Spain, Sweeden, Switzerland, UK, Ukraine, and UAE.

Lot

01072011-001; 01082010-001; 01182010-001; 01182011-001; 01272010-001; 02032011-001; 02112010-001; 02182011-001; 02242010-001; 2262011-001; 03012010-001; 03072010-001; 03132009-001; 03242009-001; 03292011-001; 03302011-001; 04012010-001; 04082010-001; 04192011-001; 04202011-001; 04302010-001; 05072010-001; 05132011-001; 05152009-001; 05242010-001; 05262010-001; 06012008-001; 06042009-001; 06062009-001; 06082010-001; 06182010-001; 06192009-001; 07082010-001; 07092010-001; 07142009-001; 07152011-001; 07272010-001; 08082009-001; 08122009-001; 08122010-001; 08132009-001; 08152010-001; 09072009-001; 09132010-001; 09142010-001; 09172009-001; 09222009-001; 09222010-001; 10012009-001; 10082009-001; 10082010-001; 10142009-001; 10182010-001; 10222010-001; 10252009-001; 10312010-001; 11162010-001; 11242009-001; 11292010-001; 12052010-001; 12072009-001; 12142009-001; 12152009-001; 12162008-001; 12182008-001; 12222010-001

Risk classification

Class II

Area (FDA)

device

Country

United States