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Villa Sistemi Medicali S.P.A Recalls
8 recalls on record · March 15, 2017 to January 8, 2020 · Medical Devices
Recalls by year
17
20
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 8, 2020Medical DevicesFDA
Villa Sistemi Medicali S.P.A. recalls Apollo EZ, Model Number 9784152036 - Product Usage: The Apollo EZ remote-controlled table is X-ray equipment that can be
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.
January 8, 2020Medical DevicesFDA
Villa Sistemi Medicali S.P.A. recalls Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an X-ray equipment that a
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.
January 8, 2020Medical DevicesFDA
Villa Sistemi Medicali S.P.A. recalls Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo table is a remote controlled X-ray syst
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.
January 8, 2020Medical DevicesFDA
Villa Sistemi Medicali S.P.A. recalls Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and
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.
March 15, 2017Medical DevicesFDA
Villa Sistemi Medicali S.P.A. recalls Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and
Hazard: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
March 15, 2017Medical DevicesFDA
Villa Sistemi Medicali S.P.A. recalls Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs an
Hazard: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
March 15, 2017Medical DevicesFDA
Villa Sistemi Medicali S.P.A. recalls Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Produc
Hazard: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.
March 15, 2017Medical DevicesFDA
Villa Sistemi Medicali S.P.A. recalls Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and gene
Hazard: Patient fell from the table because the footrest of the device detached from the table top while the patient was positioned on the table and table was moving from vertical position.