Class 2 Device Recall Juno DRF System

• Date Initiated by Firm: August 02, 2013
• Date Posted: September 13, 2013
• Recall Status: Terminated on July 25, 2016
• Recall Number: Z-2160-2013
• Recall Event ID: 66024
• 510(K)Number: K050190
• Product Classification: Table, radiologic - Product Code KXJ
• Product: Juno DRF System. Mobile X-ray system; ; These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures
• Code Information: PN 709020
• Recalling Firm/ Manufacturer: Villa Radiology Systems LLC; 91 Willenbrock Rd Ste B1; Oxford CT 06478-1036
• For Additional Information Contact: Walter Schnieder; 203-262-8836
• Manufacturer 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
• FDA Determined Cause: Radiation Control for Health and Safety Act
• Action: The Center for Devices and Radiological Health (CDRH) understands that the Villa Sistemi Medicali (U.S. Agent: Villa Radiology Systems) is responsible for the correction of all 22 noncompliant units distributed within the U.S. Should the CAP prove ineffective in bringing the noncompliant unit(s) in the field into compliance with the applicable performance standard, the CDRH can require more stringent measures to obtain compliance. The system will be modified by upgrading the generator power firmware, which will bring Juno DRF x-ray system into compliance. You provided a verification and validation test report (Juno DRF System AK fix-DAM Prom V&V Test Report) to FDA demonstrating that these proposed upgrades addressed the problem. Field service engineers will schedule an appointment with customers to install the new software. 2. The customer notification letter (URGENT: Electronic Product Radiation Warning), dated August 02, 2013, includes the statement that "the manufacturer will, without charge, remedy the defect or bring the product into compliance with each applicable Federal standard in accordance with a plan to be approved by the Secretary of Health and Human Services, the details of which will be included in a subsequent communication to you." 3. The CAP will be completed within a six month timeframe (by March 1, 2014). 4. The manufacturer will notify the Secretary on monthly basis providing progress with the field correction. CDRH approves the CAP subject to the following conditions: Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. For further questions please call (203) 262-8836.
• Quantity in Commerce: 22 units within US
• Distribution: US Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KXJ and Original Applicant = VILLA SISTEMI MEDICALI S.P.A.