No packaging. The device is a computed tomography scanner. Intended to provide corss sectio...
FDA Recall #Z-2678-2014 — Class II — January 9, 2007
Product Description
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.
Reason for Recall
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Recalling Firm
Philips Medical Systems (Cleveland) Inc — Cleveland, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
61
Distribution
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.
Code Information
Model 728243 Software version 2.2.1 and 2.2.2
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated