Class 2 Device Recall Villa Sistemi Medical S.P.A Apollo DRF

• Date Initiated by Firm: December 27, 2016
• Create Date: March 09, 2017
• Recall Status: Terminated on March 09, 2021
• Recall Number: Z-1429-2017
• Recall Event ID: 76367
• 510(K)Number: K050190
• Product Classification: Table, radiologic - Product Code KXJ
• Product: Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
• Code Information: 08090531 09090591 10040680 15051450 11020798
• Recalling Firm/ Manufacturer: Villa Sistemi Medicali S.P.A.; Via delle Azalee 3; Buccinasco Italy
• For Additional Information Contact: Ernesto Filizzola; 203-2628836
• Manufacturer Reason for Recall: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Customers were notified of the recall via DHL or similar mail service. The letter identified the affected product, problem and actions to be taken.
• Quantity in Commerce: 65 devices in total
• Distribution: 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, PA, Puerto Rico, TN, TX, UT, and W.I
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KXJ