Product Wiki · Recalls · U.S. FDA — Device Enforcement

Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs and general fluoroscopy procedures — recall Z-2160-2013

U.S. FDA — Device Enforcement · United States · 2013-08-02 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2160-2013
Date of alert
2013-08-02
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Villa Radiology Systems LLC
Product category
device
Product type
Devices
Reported risk: 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
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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