Villa Sistemi Medicali S.P.A.: Medical Device Recall in 2020 - (Recall #: Z-0766-2020)

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 EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used 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-0766-2020

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: 1

Code Information:

Serial Numbers: 13101261

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