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Villa Radiology Systems Recalls
8 recalls on record · September 25, 2013 to February 1, 2017 · Medical Devices
Recalls by year
13
15
17
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
February 1, 2017Medical DevicesFDA
Villa Radiology Systems LLC recalls Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy proce
Hazard: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
February 1, 2017Medical DevicesFDA
Villa Radiology Systems LLC recalls Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy proc
Hazard: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
February 1, 2017Medical DevicesFDA
Villa Radiology Systems LLC recalls Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784120131, 9784120231, 9784130131 Multi-
Hazard: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
February 1, 2017Medical DevicesFDA
Villa Radiology Systems LLC recalls Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radiograph and general fluoroscopy procedures
Hazard: The analysis showed that the incident was caused by a chain of four faults: 1.) The injured person overcame a physical barrier (the tabletop support arm. height ca. 60 em) to access a prohibited area not intended as a working position. 2) The directions for use (device labeling and instructions for use) did not contain an explicit exclusion of the prohibited area. 3.) The movement was activated inadvertently and continuously. and it was not released (the movement requires continuous activation). 4.) Delayed activation of the emergency stop.
November 18, 2015Medical DevicesFDA
Villa Radiology Systems LLC recalls Owandy Radiology I -MAX Touch 3D X-ray
Hazard: It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
November 18, 2015Medical DevicesFDA
Villa Radiology Systems LLC recalls Villa Sistemi Rotograph EVO 3D X-ray
Hazard: It has been discovered that due to lack of information accompanying documents the product fails to comply with 21CfR 1020.33(c),1020.33(d),1020.33(g),and 1020.330).
March 18, 2015Medical DevicesFDA
Villa Radiology Systems LLC recalls Juno DFR X-ray system
Hazard: The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality
September 25, 2013Medical DevicesFDA
Villa Radiology Systems LLC recalls Juno DRF System. Mobile X-ray system These are general, multi-function x-ray systems capable of routine radiographs a
Hazard: 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