Villa Sistemi Medicali S.P.A. recalls Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that…

Recall date

November 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0765-2020

FDA classification

Class II

Brand / firm

Villa Sistemi Medicali S.P.A.

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.