Villa Sistemi Medicali S.P.A. Via delle Azalee 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 or injuries. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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.

Recommended Action

Per FDA guidance

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 years to the replacement date. All the examinations performed on the device before the recall remain valid. The IFU and the Service Manual need to be amended to prescribe the replacement of the angulation chain after 8 years of service life of the unit. This notice needs to be passed to all users of Apollo, Apollo DRF, Apollo EZ and to all those who need to be aware within your organisation or to any organisation where the potentially affected devices have been transferred.