RecallDepth

Apollo EZ; Model: 9784152036 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-1430-2017
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 Number: 13101261

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.

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