Device product
Philips Multi Diagnost Eleva II
Z-1044-2015
Product summary
- Event
- Event 69870
- Status
- Terminated
- Classification
- Class II
- Quantity
- 238
- Official record key
device-enforcement:Z-1044-2015
Official wording
Reason: The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.
Code information: Product Code: 708036
Distribution pattern: Worldwide Distribution - USA ( nationwide ) to the states of : AR, AZ, CA, CO, DE, FL, GA, HI, IL, IA, KY, KS, LA, MI, MO, MS, NC, NY, OH, PA, TN, TX, VA, VT, WA, WY and WV., and the countries of Austria, Australia, Colombia, Germany, Switzerland, Turkey, Ireland, Dubia and United Kingdom.
Derived failure modes
-
Unknown
The possibility of the Reference Air Kerma Rate for low dose mode will not be reduced to 50% of the value for the normal mode, but will be approximately 70-80%, leading to a higher patient dose than expected.