Device 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.
Z-2678-2014
Product summary
- Event
- Event 69102
- Status
- Terminated
- Classification
- Class II
- Quantity
- 61
- Official record key
device-enforcement:Z-2678-2014
Official wording
Reason: When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.
Code information: Model 728243 Software version 2.2.1 and 2.2.2
Distribution pattern: 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.
Derived failure modes
-
Unknown
When the Extended Display Firled ov View reconstruction is used, the CT numbers and anatomy in teh extended region are not accurate.