Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of...
FDA Recall #Z-1429-2017 — Class II — December 27, 2016
Product Description
Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
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.
Recalling Firm
Villa Sistemi Medicali S.P.A. — Buccinasco, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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
Code Information
08090531 09090591 10040680 15051450 11020798
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated