Reported Jan 8, 2020 · Ongoing
Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that…
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 DRF
- Model Number 9784220831 - Product UsageThe remote controlled table Apollo DRF is an X-ray equipment that allows 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 Numbers08090531 09090591 10040680 15051450 11020798 17011602 17041639
- Amount recalled
- 7
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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