The Recall Desk

FDA (Devices) recall action 84309

Villa Sistemi Medicali S.P.A. recalled 4 products on 2020-01-08

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2020-01-08
Critical
0
Units
57

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–4 of 4

  • HighFDA (Devices)··2020-01-08

    Villa Sistemi Medicali Recalls Apollo EZ X-Ray Table Due to Chain Failure

    Villa Sistemi Medicali is recalling one Apollo EZ X-ray table because the angulation chain may fail early due to metal fatigue.

    Product
    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 motori
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2020-01-08

    Villa Sistemi Medicali Recalls Apollo DRF X-ray Tables Due to Chain Failure

    Villa Sistemi Medicali is recalling seven Apollo DRF X-ray tables because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo DRF, Model Number 9784220831 - Product Usage: The 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 motori
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2020-01-08

    Villa Sistemi Medicali Recalls Apollo X-ray Tables Due to Chain Failure Risk

    Villa Sistemi Medicali is recalling three Apollo X-ray tables because the angulation chain may fail early due to metal fatigue.

    Product
    Apollo, Model Numbers 9784100231, 9784120131, 9784130131 - Product Usage: Apollo 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 remo
    Category
    Distribution
    26 states
  • HighFDA (Devices)··2020-01-08

    Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Chain Failure

    Villa Sistemi Medicali is recalling 46 Juno DRF x-ray systems because the angulation chain may fail early due to metal fatigue.

    Product
    Juno DRF, Model Number 709020 - Product Usage: General. multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
    Category
    Distribution
    26 states