Device product
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Z-2160-2013
Product summary
- Event
- Event 66024
- Status
- Terminated
- Classification
- Class II
- Quantity
- 22 units within US
- Official record key
device-enforcement:Z-2160-2013
Official wording
Reason: It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6
Code information: PN 709020
Distribution pattern: US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.
Derived failure modes
-
Unknown
It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6