Class II — Villa Sistemi Medicali S.P.A.
| Recalling firm | Villa Sistemi Medicali S.p.A. |
|---|---|
| Registered facility | VILLA SISTEMI MEDICALI S.P.A. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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. |
| Quantity | 65 devices in total |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, CT, DC, FL, IA, IL, IN, LA, MA, MD, MI, MN, MO, MS, NJ, NY, PA, Puerto Rico, TN, TX, UT, and W.I |
| Initiated | 2016-12-27 |
| Classified | 2017-03-09 |
| Terminated | 2021-03-09 |
| Recall number | Z-1428-2017 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Villa Sistemi Medicali S.P.A. (Z-1428-2017).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/76367/
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