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 | Ongoing |
| Reason | 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. |
| 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 motorized and remote-controlled. Medical purpose is the diagnosis, visualization and documentation of various human diseases or injuries. |
| Quantity | 7 |
| 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, OH, OK, PA, TN, TX, UT, and Puerto Rico. |
| Initiated | 2019-11-04 |
| Classified | 2019-12-31 |
| Recall number | Z-0765-2020 |
| 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-0765-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84309/
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