Recall Z-1079-2015 ยท KXJ Table, Radiologic
Villa Radiology Systems LLC
Juno DFR X-ray system
| Date | Mar 6, 2015 (initiated Dec 14, 2014) |
| Status | Terminated |
| Reason | The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Planned Action by the firm: 1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge. 2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan 1. Notification of all dealers a |
| Quantity | 30 units distributed in the US |
| Distribution | US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050190 | APOLLO Villa Sistemi Medicali S.P.A., Mar 25, 2005 |