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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

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
Recall Number Z-2160-2013
Classification Class II
Code Info PN 709020
Product Distributed Qty 22 units within US
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

Event Detail

Event Id 66024
Product Type Devices
Status Ongoing
Recalling Firm Villa Radiology Systems LLC
City Oxford
State CT
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-08-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern US Nationwide Distribution including the states of AZ, MI, IN, UT, CT, AL, NY, PA, IL, MD, CA, MA, IA, OH, MS and MO.