Z-0651-2016 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 3, 2016
- Initiation Date
- September 4, 2014
- Termination Date
- December 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 832 systems
Product Description
Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ray System is a class II extra oral X-Ray system used to provide dental radiographic examination and diagnosis of diseases of the teeth, jaw and oral structures. When the system is equipped with the cephalometric option, the system will also provide cephalometric radiographic examinations for use in orthodontic treatment planning and evalu
Reason for Recall
Failure of the primary collimator may result in unintentional movement of the device. The unintentional movement will not result in the generation of an error message.
Distribution Pattern
Worldwide Distribution - US including AL, AR, AZ, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NE, NJ, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI; and Internationally to Australia, Belgium, Canada, Czech Republic, France, Hungary, Lithuania, New Zealand, Poland, Russia, Saudi Arabia, South Africa, Switzerland, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Code Information
Model Number: 60-A0001; ZA05002 , ZA05003 , ZA05004 , ZA05005 , ZA05006 , ZA05007 , ZA05008 , ZA05009 , ZA05010 , ZA05011 , ZA05012 , ZA05013 , ZA05014 , ZA05015 , ZA05016 , ZA05017 , ZA05018 , ZA05019 , ZA05020 , ZA05021 , ZA05022 , ZA05023 , ZB51001 , ZB51002 , ZB51003 , ZB51004 , ZB51007 , ZB51008 , ZB51009 , ZB51010 , ZB51011 , ZB51012 , ZB51013 , ZB51014 , ZB51015 , ZB51016 , ZB51017 , ZB51018 , ZB51019 , ZB51021 , ZB51023 , ZB51024 , ZB51025 , ZB51026 , ZB51027 , ZB51028 , ZB51029 , ZB51030 , ZB51031 , ZB51032 , ZB51034 , ZB51035 , ZB51036 , ZB52001 , ZB52002 , ZB52003 , ZB52004 , ZB52005 , ZB52006 , ZB52007 , ZB52008 , ZB52009 , ZB52010 , ZB52011 , ZB52012 , ZB52013 , ZB52014 , ZB52015 , ZB52016 , ZB52017 , ZB52018 , ZB52019 , ZB52020 , ZB52021 , ZB52022 , ZB52023 , ZB92002 , ZB92003 , ZB92004 , ZB92005 , ZB92006 , ZB92007 , ZB92008 , ZB92009 , ZB92011 , ZC38001 , ZC38002 , ZC38003 , ZC38004 , ZC38005 , ZC38007 , ZC38008 , ZC38009 , ZC38010 , ZC38011 , ZC38013 , ZC38015 , 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