Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0766-2020 — Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be used to perform general radiographic and fluoroscopic examinations. The system is a fixed position type. The movements of the table and tube support are motorized and remote-contr

U.S. FDA — Device Enforcement · Italy · 2019-11-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0766-2020
Date of alert
2019-11-04
Country / jurisdiction
Italy
Risk level
Class II
Risk type
recall
Brand
Villa Sistemi Medicali S.P.A.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
13101261
Reported risk: An amendment to the IFU and Service Manual is being issued to prescribe the replacement of the angulation chain after 8 years of service of the of the unit. After testing, it was found that due to metal fatigue under sever workload conditions, the angulation chain might fail before the expected lifetime of 10 years.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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