Recall Z-1428-2017 ยท KXJ Table, Radiologic
Villa Sistemi Medicali S.P.A.
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
| Date | Dec 27, 2016 |
| Status | Terminated |
| Reason | Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position. |
| Root cause | Nonconforming Material/Component |
| Action | Customers were notified of the recall via DHL or similar mail service. The letter identified the affected product, problem and actions to be taken. |
| Quantity | 65 devices in total |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050190 | APOLLO Villa Sistemi Medicali S.P.A., Mar 25, 2005 |