PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: May 8, 2013 Initiated: March 28, 2013 #Z-1211-2013

Product Description

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.

Reason for Recall

Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.

Details

Recalling Firm
GE Healthcare, LLC
Units Affected
70
Distribution
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.
Location
Waukesha, WI

Frequently Asked Questions

What product was recalled?
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.. Recalled by GE Healthcare, LLC. Units affected: 70.
Why was this product recalled?
Coolant supply lines may leak liquid onto the floor resulting in a slippery surface and fall hazard.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 8, 2013. Severity: Moderate. Recall number: Z-1211-2013.