Z-2160-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 25, 2013
- Initiation Date
- August 2, 2013
- Termination Date
- July 25, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units within US
Product Description
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
Reason for Recall
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
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.
Code Information
PN 709020