Z-1429-2017 Class II Terminated

Recalled by Villa Sistemi Medicali S.P.A. — Buccinasco, N/A

Recall Details

Product Type
Devices
Report Date
March 15, 2017
Initiation Date
December 27, 2016
Termination Date
March 9, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
65 devices in total

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.

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, PA, Puerto Rico, TN, TX, UT, and W.I

Code Information

08090531 09090591 10040680 15051450 11020798