Recall Z-0765-2020 ยท KXJ Table, Radiologic
Villa Sistemi Medicali S.P.A.
Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that allows to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases o
| Date | Nov 4, 2019 |
| Status | Open, Classified |
| Reason | An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years. |
| Root cause | Device Design |
| Action | Urgent Field Safety Notice notification letters dated 10/23/19 were sent to customers. Action to be taken by the customer/user: The user shall take note of amendment/reinforcement of Instructions for Use (IFU) and Service Manual, attached to this FN and, if it is the case, request a service technician to do the periodic preventive maintenance the user shall replace the attached pages in the User Manual and in the Service Manual, prescribing the periodic replacement of the angulation chain. Fill the table present in the addendum; In the cell "Next replacement date" write the date adding 8 yea |
| Quantity | 7 |
| 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, OH, OK, PA, TN, TX, UT, and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050190 | APOLLO Villa Sistemi Medicali S.P.A., Mar 25, 2005 |