RecallDepth

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.

Company
Villa Sistemi Medicali S.P.A. Via Delle Azalee
Recall Initiated
December 27, 2016
Terminated
March 9, 2021
Recall Number
Z-1428-2017
Quantity
65 devices in total

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

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

Lot / Code Info

Serial Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446

Root Cause

Nonconforming Material/Component

Action Taken

Customers were notified of the recall via DHL or similar mail service. The letter identified the affected product, problem and actions to be taken.

More recalls by Villa Sistemi Medicali S.P.A. Via Delle Azalee

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