Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable o...

FDA Device Recall #Z-2160-2013 — Class II — August 2, 2013

Recall Summary

Recall Number Z-2160-2013
Classification Class II — Moderate risk
Date Initiated August 2, 2013
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Villa Radiology Systems LLC
Location Oxford, CT
Product Type Devices
Quantity 22 units within US

Product Description

Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures

Reason for Recall

It has been discovered that the Air Kerma rate information is inconsistent in Continuous Fluoro modes 30x30 (12"x12") and 15x15 (6"x6). This could result in a deviation of the displayed values of Air Kerma Rate and Cumulated Air Kerma from the actual values greater then +/-35% and then in a failure to comply with the requirements of 21 CFR 1020.32(k)(6

Distribution Pattern

US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.

Lot / Code Information

PN 709020

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-1063-2017 Class II Juno DRF; Model: 709020 Multi-function x-ray... 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

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.