Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general...
FDA Device Recall #Z-1063-2017 — Class II — February 19, 2016
Recall Summary
| Recall Number | Z-1063-2017 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 19, 2016 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Villa Radiology Systems LLC |
| Location | Oxford, CT |
| Product Type | Devices |
| Quantity | 66 distributed in US |
Product Description
Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures.
Reason for Recall
The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
Distribution Pattern
AL AZ CA CO CT DC FL IA IL IN LA MA MD MI MN MO MS NJ NY OH PA Puerto Rico TN TX UT WI
Lot / Code Information
10110770 11030805 11030806 11070845 11070848 11070849 11090864 11110900 12020978 12020982 12030999 12041003 12061014 12061018 12061020 12081040 12091074 12101104 12121186 12121187 13031215 13101263 14021301 14031313 14041321 14051332 14071353 14081359 14091368 14091371 14121400 14121403 15021426 15031440 15041444 15091473 15091478 15101484 15101487
Other Recalls from Villa Radiology Systems LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1064-2017 | Class II | Apollo: Models: 9784000131, 9784000231, 9784020... | Feb 19, 2016 |
| Z-1065-2017 | Class II | Apollo DRF: Model: 9784220831 Multi-function... | Feb 19, 2016 |
| Z-1066-2017 | Class II | Apollo EZ: Model: 9784152036 Multi-function ... | Feb 19, 2016 |
| Z-0129-2016 | Class II | Owandy Radiology I -MAX Touch 3D X-ray | Aug 5, 2015 |
| Z-0128-2016 | Class II | Villa Sistemi Rotograph EVO 3D X-ray | Aug 5, 2015 |
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.