Reported Jan 8, 2020 · Ongoing
Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can…
Villa Sistemi Medicali S.P.A.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Villa Sistemi Medicali S.P.A. · Via delle Azalee 3 · Buccinasco, N/A · N/A
Is this the product you have?
- Apollo EZ
- Model Number 9784152036 - Product UsageThe 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-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries
- Lot codes and dates
- Serial Numbers13101261
- Amount recalled
- 1
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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