Villa Sistemi Medicali S.P.A.: Medical Device Recall in 2020 - (Recall #: Z-0764-2020)

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, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely 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-0764-2020

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: 3

Code Information:

Serial Numbers: 08020473 11100873 15041446

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