# FDA recall Z-0765-2020

> **Villa Sistemi Medicali S.P.A.** · Class II · device recall initiated 2019-11-04.

## 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.

## Reason for recall

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.

## 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.

## Key facts

- **Recall number:** Z-0765-2020
- **Recalling firm:** Villa Sistemi Medicali S.P.A.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-11-04
- **Report date:** 2020-01-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buccinasco, N/A, Italy

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0765-2020

## Citation

> AI Analytics. FDA recall Z-0765-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0765-2020. Source: US FDA. Licensed CC0.

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