The Recall Desk

FDA (Devices) recall action 76367

Villa Sistemi Medicali S.P.A. recalled 4 products on 2017-03-15

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
2017-03-15
Critical
0
Units
260

Why these products were recalled

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.

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

  • SevereFDA (Devices)··2017-03-15

    Villa Sistemi Medicali Recalls Apollo X-Ray Systems Due to Footrest Detachment

    Villa Sistemi Medicali is recalling 65 Apollo multi-function x-ray systems because the footrest detached from the table, causing a patient to fall.

    Product
    Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 9784120231 9784130131 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures.
    Category
    Distribution
    24 states
  • HighFDA (Devices)··2017-03-15

    Villa Sistemi Medicali Recalls Juno DRF X-Ray Systems Due to Footrest Detachment

    Villa Sistemi Medicali is recalling 65 Juno DRF x-ray systems because the footrest can detach from the table, causing patients to fall.

    Product
    Juno DRF; Model: 709020 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Distribution
    24 states
  • SevereFDA (Devices)··2017-03-15

    Apollo DRF X-ray Systems Recalled Due to Footrest Detachment Hazard

    Villa Sistemi Medicali is recalling 65 Apollo DRF x-ray systems because the footrest can detach, causing patients to fall from the table.

    Product
    Apollo DRF; Model: 9784220831 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Distribution
    24 states
  • SevereFDA (Devices)··2017-03-15

    Villa Sistemi Medicali Recalls Apollo EZ X-Ray Systems Due to Footrest Detachment

    Villa Sistemi Medicali is recalling 65 Apollo EZ x-ray systems because the footrest detached from the table, causing a patient to fall.

    Product
    Apollo EZ; Model: 9784152036 Product Usage: General, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
    Category
    Distribution
    24 states