Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 978412023...
FDA Recall #Z-1428-2017 — Class II — December 27, 2016
Product Description
Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 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
Serial Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated