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U.S. Department of Health and Human Services

Class 2 Device Recall Juno DFR Xray system

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  Class 2 Device Recall Juno DFR Xray system see related information
Date Initiated by Firm December 14, 2014
Date Posted March 06, 2015
Recall Status1 Terminated 3 on March 16, 2017
Recall Number Z-1079-2015
Recall Event ID 70241
510(K)Number K050190  
Product Classification Table, radiologic - Product Code KXJ
Product Juno DFR X-ray system
Code Information P/N 709020
Recalling Firm/
Villa Radiology Systems LLC
91 Willenbrock Rd Ste B1
Oxford CT 06478-1036
Manufacturer Reason
for Recall
The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
FDA Determined
Cause 2
Radiation Control for Health and Safety Act
Action Planned Action by the firm: 1. You will send out a customer notification letter that identified the software corrective actions and that indicates that these corrective actions will be provided to the end-user free of charge. 2. You will implement a corrective software patch so that kV and mA manual adjustments from the generator console are inhibited, and consequently no high-level control modality is allowed. In AERC, high-level control is already disabled. A Field Service Engineer is to implement the software patch according to the corrective action plan 1. 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 The system shall be modified upgrading the generator power firmware which will inhibit the high-level control bringing the system into compliance. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification. 2. You will implement the corrective software patch to inhibit high-level control according to the corrective action plan by June 22, 2015. For further questions please 203.262-8836
Quantity in Commerce 30 units distributed in the US
Distribution US Distribution to the states of: AZ, AL, CA, CO, CT, DC, FL, IA, IL, IN, MI, MD, MS, MA, MO, NY, OH, PA, UT, TN and TX.
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.