Recall Z-0764-2020— Villa Sistemi Medicali S.P.A.

Name: FDA recall Z-0764-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-04

Class II · Ongoing

Class II FDA medical device recall by Villa Sistemi Medicali S.P.A., initiated 2019-11-04. It names one FDA 510(k) clearance: K050190. Product: 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.. Reason: 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..

Recalling firm: Villa Sistemi Medicali S.P.A.
Classification: Class II
Status: Ongoing
Initiated: 2019-11-04
Firm location: Buccinasco, N/A, Italy

510(k) clearances named in this recall

1 on FDA's record

K050190 — APOLLOVilla Sistemi Medicali S.P.A.·cleared 2005-03-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.