Reported Jan 8, 2020 · Ongoing
Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray…
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?
ApolloModel Numbers 978410023197841201319784130131 -
- Product UsageApollo table is a remote controlled X-ray system suitable for radiography and fluoroscopy examinations. The system is stationary mounted. The movements of the table and the tube stand are motorized and remotely controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries
- Lot codes and dates
- Serial Numbers08020473 11100873 15041446
- Amount recalled
- 3
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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