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Philips Medical Systems (Cleveland) Inc recalls No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human
Recalled October 1, 2014 · FDA recall Z-2678-2014 · Philips Medical Systems (Cleveland)
Hazard
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate. · FDA Class II
Units
61
Sold at
Worldwide Distribution - US including MO, TX, MD, AR, VA, KY, RI, NJ, MA, NY, LA, PA, VT, SC, CA, OH, FL, MN, MI and Internationally to Netherlands, Canada, Finland, Austria, France, Malaysia, Denmark, Norway, UK, Australia, Belgium, New Zealand.
Description
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Product
No packaging. The device is a computed tomography scanner. Intended to provide corss sectional images of the human body and visualization of the internal organs of the body.
Manufacturer(s)
Philips Medical Systems (Cleveland) Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →