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.
This recall has been terminated (originally issued September 22, 2014).
- Recall Initiated
- January 9, 2007
- Posted
- September 22, 2014
- Terminated
- November 6, 2015
- Recall Number
- Z-2678-2014
- Quantity
- 61
- Firm Location
- Cleveland, OH
- Official Source
- View on FDA website ↗
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.
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.
Lot / Code Info
Model 728243 Software version 2.2.1 and 2.2.2
Root Cause
Labeling design
Action Taken
Philips sent a Product Safety Notification letter dated December 21, 2006 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to distribute the Product Safety Notification to all affected users and keep a copy of the notification with the Instructions for Use until further notice. Customers with questions were instructed to contact Customer Care Center at 1-800-722-9377, option 5 - Diagnostic Imaging, option 1 - CT. For questions regarding this recall call 440-483-7600.