Recall Z-2160-2013 ยท KXJ Table, Radiologic
Villa Radiology Systems LLC
Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
| Date | Sep 13, 2013 (initiated Aug 2, 2013) |
| Status | Terminated |
| 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 |
| Root cause | Radiation Control for Health and Safety Act |
| Action | The Center for Devices and Radiological Health (CDRH) understands that the Villa Sistemi Medicali (U.S. Agent: Villa Radiology Systems) is responsible for the correction of all 22 noncompliant units distributed within the U.S. Should the CAP prove ineffective in bringing the noncompliant unit(s) in the field into compliance with the applicable performance standard, the CDRH can require more stringent measures to obtain compliance. The system will be modified by upgrading the generator power firmware, which will bring Juno DRF x-ray system into compliance. You provided a verification and valid |
| Quantity | 22 units within US |
| Distribution | US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050190 | APOLLO Villa Sistemi Medicali S.P.A., Mar 25, 2005 |