FDANovember 4, 2019device

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-co...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Ongoing

Brands named

villa sistemi medicali s p avillavilla sistemi

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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-co... — Recall Details · AllClear