Apollo DRF, Model Number 9784220831 - Product Usage: The remote controlled table Apollo DRF is an...
FDA Device Recall #Z-0765-2020 — Class II — November 4, 2019
Recall Summary
| Recall Number | Z-0765-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 4, 2019 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Villa Sistemi Medicali S.P.A. |
| Location | Buccinasco, N/A |
| Product Type | Devices |
| Quantity | 7 |
Product Description
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 Pattern
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.
Lot / Code Information
Serial Numbers: 08090531 09090591 10040680 15051450 11020798 17011602 17041639
Other Recalls from Villa Sistemi Medicali S.P.A.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0763-2020 | Class II | Juno DRF, Model Number 709020 - Product Usage: ... | Nov 4, 2019 |
| Z-0766-2020 | Class II | Apollo EZ, Model Number 9784152036 - Product Us... | Nov 4, 2019 |
| Z-0764-2020 | Class II | Apollo, Model Numbers 9784100231, 9784120131, 9... | Nov 4, 2019 |
| Z-1427-2017 | Class II | Juno DRF; Model: 709020 Product Usage: Gene... | Dec 27, 2016 |
| Z-1428-2017 | Class II | Apollo; Models: 9784000131 9784000231 9784020... | Dec 27, 2016 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.