Device product
Mobile Diagnostic X-Ray System with Digital Panel
Z-1706-2017
Product summary
- Event
- Event 64902
- Status
- Terminated
- Classification
- Class II
- Quantity
- 220 systems
- Official record key
device-enforcement:Z-1706-2017
Official wording
Reason: When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.
Code information: *** All units ***
Distribution pattern: Nationwide (AR, AZ, CA, DE, FL, GA, IA, IL, IN, KS, MD, MI, MN, NC, NM, NY, OH, OR, PA, SC, TX, VT, WI)
Derived failure modes
-
Unknown
When the operator moves an image to another view then the electronic marker might be placed at the wrong anatomical position in the resulting image.