Apollo; Models: 9784000131 9784000231 9784020131 9784020231 9784100231 9784120131 978412023...
FDA Device Recall #Z-1428-2017 - Class II, December 27, 2016
Recall Summary
| Recall Number | Z-1428-2017 |
| Classification | Class II - Moderate risk |
| Date Initiated | December 27, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Villa Sistemi Medicali S.P.A. |
| Location | Buccinasco, N/A |
| Product Type | Devices |
| Quantity | 65 devices in total |
Product Description
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.
Reason for Recall
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.
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, PA, Puerto Rico, TN, TX, UT, and W.I
Lot / Code Information
Serial Numbers: 06100127 06110138 07010149 07020158 07020163 07020165 07030171 07040206 09010566 09090605 10100752 11100873 15041446
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-0765-2020 | Class II | Apollo DRF, Model Number 9784220831 - Product U... | 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 |
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.