Villa Sistemi Medicali S.P.A.: Medical Device Recall in 2020 - (Recall #: Z-0765-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: November 4, 2019

Date Posted: January 8, 2020

Recall Number: Z-0765-2020

Event ID: 84309

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 7

Code Information:

Serial Numbers: 08090531 09090591 10040680 15051450 11020798 17011602 17041639

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated