Home / Recalls / Villa Radiology Systems LLC / Z-0128-2016

Z-0128-2016 Class II Terminated

Recalled by Villa Radiology Systems LLC — Oxford, CT

Recall Details

Product Type
Devices
Report Date
November 18, 2015
Initiation Date
August 5, 2015
Termination Date
March 22, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
Rotograph EVO 3D - 8 installed

Product Description

Villa Sistemi Rotograph EVO 3D X-ray

Reason for Recall

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).

Distribution Pattern

US Distribution

Code Information

p/n 9307251291, 9307351291, 9307651291

Other recalls by Villa Radiology Systems LLC

  • Z-1063-2017 Class II — Juno DRF; Model: 709020 Multi-function x-ray systems capable of routine radio (February 19, 2016)
  • Z-1064-2017 Class II — Apollo: Models: 9784000131, 9784000231, 9784020131, 9784020231, 9784100231, 9784 (February 19, 2016)
  • Z-1065-2017 Class II — Apollo DRF: Model: 9784220831 Multi-function x-ray systems capable of routine (February 19, 2016)
  • Z-1066-2017 Class II — Apollo EZ: Model: 9784152036 Multi-function x-ray systems capable of routine (February 19, 2016)
  • Z-0129-2016 Class II — Owandy Radiology I -MAX Touch 3D X-ray (August 5, 2015)
  • Z-1079-2015 Class II — Juno DFR X-ray system (December 14, 2014)
  • Z-2160-2013 Class II — Juno DRF System. Mobile X-ray system These are general, multi-function x-ray (August 2, 2013)