Retiro De Equipo (Recall) de Juno DRF System

Recall

66024

Class 2

Z-2160-2013

2013-08-02

2013-09-13

Terminated

United States

2016-07-25

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=121286

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.

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.