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Device product

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

Z-0651-2016

September 04, 2014

Class II

Product summary

Firm
Midmark Corp dba Progeny Inc
Event
Event 70765
Status
Terminated
Classification
Class II
Quantity
832 systems
Official record key
device-enforcement:Z-0651-2016

Official wording

Reason: 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.

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 , ZC38016 , ZC38017 , ZC38018 , ZC38019 , ZC38020 , ZC38021 , ZC38022 , ZC39001 , ZC39002 , ZE09001 , ZE09002 , ZE09003 , ZE09004 , ZE09006 , ZE09007 , ZE09008 , ZE09009 , ZE09010 , ZE09011 , ZE09012 , ZE09014 , ZE09015 , ZE09016 , ZE09017 , ZE09018 , ZE09019 , ZE09020 , ZE47001 , ZE47002 , ZE47003 , ZE47004 , ZE47005 , ZE47006 , ZE47007 , ZE47008 , ZE47009 , ZE47010 , ZE47011 , ZE47012 , ZE47013 , ZE47014 , ZE47015 , ZE47016 , ZE47017 , ZE47018 , ZE47019 , ZE47020 , ZE47021 , ZE77001 , ZE77002 , ZE77003 , ZE77004 , ZE77005 , ZE77006 , ZE77007 , ZE77008 , ZE77009 , ZE77010 , ZF41001 , ZF41002 , ZF41003 , ZF41004 , ZF41005 , ZF41006 , ZF41007 , ZF41008 , ZF41009 , ZF41010 , ZF41011 , ZF41012 , ZF41013 , ZF41014 , ZF41015 , ZF41016 , ZF41017 , ZF41018 , ZF41019 , ZF41020 , ZF41021 , ZF41022 , ZF41023 , ZF41024 , ZF95001 , ZF95002 , ZF95003 , ZF95004 , ZF95005 , ZF95006 , ZF95007 , ZF95008 , ZF95009 , ZF95010 , ZF95011 , ZF95012 , ZF95013 , ZF95014 , ZF95015 , ZF95016 , ZF95017 , ZG61001 , ZG61002 , ZG61003 , ZG61004 , ZG61005 , ZG61006 , ZG61007 , ZG61008 , ZG61009 , ZG61010 , ZG61011 , ZG61012 , ZG61013 , ZG61014 , ZG61015 , ZG61016 , ZG61017 , ZG61018 , ZG61019 , ZG61020 , ZG61021 , ZG61022 , ZG61023 , ZG61025 , ZG61026 , ZG61027 , ZG61028 , ZG61029 , ZG93001 , ZG93002 , ZG93003 , ZG93004 , ZG93005 , ZG93006 , ZG93008 , ZG93009 , ZG93010 , ZG93011 , ZG93012 , ZG93013 , ZG93014 , ZG93015 , ZG93016 , ZG93017 , ZG93018 , ZG93019 , ZG93020 , ZG93021 , ZG93022 , ZG93023 , ZG93024 , ZH20001 , ZH20002 , ZH20003 , ZH20004 , ZH20005 , ZH20006 , ZH20007 , ZH20008 , ZH20009 , ZH20010 , ZH20011 , ZH20012 , ZH20013 , ZH20014 , ZH20016 , ZH20017 , ZH20019 , ZH20020 , ZH20021 , ZH20022 , ZH20023 , ZH20024 , ZH20025 , ZH20026 , ZH20027 , ZH20028 , ZH20029 , ZH36001 , ZH36002 , ZH36003 , ZH36004 , ZH36005 , ZH36006 , ZH36007 , ZH36008 , ZH36009 , ZH36011 , ZH36012 , ZH36013 , ZH36014 , ZH36015 , ZH36016 , ZH36018 , ZH37002 , ZH37003 , ZH37004 , ZH37005 , ZH37006 , ZH37007 , ZH37008 , ZH37009 , ZH37010 , ZH37012 , ZH37013 , ZH37014 , ZH37015 , ZJ26001 , ZJ26002 , ZJ26003 , ZJ26004 , ZJ26005 , ZJ26006 , ZJ26007 , ZJ26008 , ZJ26009 , ZJ26010 , ZJ26011 , ZJ26012 , ZJ26013 , ZJ26014 , ZJ26015 , ZJ26016 , ZJ26017 , ZJ26018 , ZJ26019 , ZJ26020 , ZJ26021 , ZJ26022 , ZJ26023 , ZJ26024 , ZJ26025 , ZJ26026 , ZJ26027 , ZJ26028 , ZK04002 , ZK04003 , ZK04004 , ZK04005 , ZK04006 , ZK51001 , ZK51002 , ZK51003 , ZK51004 , ZK51005 , ZK51006 , ZK51007 , ZK51008 , ZK51009 , ZK51010 , ZK51011 , ZK51012 , ZK51013 , ZK51015 , ZK51016 , ZK51017 , ZK58001 , ZK58002 , ZK58003 , ZK58004 , ZK58005 , ZK58006 , ZK58007 , ZK58008 , ZK58009 , ZK58010 , ZK58011 , ZK58012 , ZK58013 , ZK58014 , ZK58015 , ZK58016 , ZK58017 , ZK58018 , ZK58019 , ZK58020 , ZK58021 , ZK58022 , ZK58023 , ZK58024 , ZM18018 , ZM81001 , ZM81002 , ZM81003 , ZM81004 , ZM81005 , ZM81006 , ZM81007 , ZM81008 , ZM81009 , ZM81010 , ZM81011 , ZM81012 , ZM81013 , ZM81014 , ZM81015 , ZM81016 , ZM81017 , ZM81018 , ZM81019 , ZM81020 , ZM81021 , ZM81022 , ZM81023 , ZM81025 , ZM81026 , ZM81027 , ZM81029 , ZM81030 , ZM81031 , ZN44001 , ZN44002 , ZN44003 , ZN44004 , ZN44005 , ZN44006 , ZN44007 , ZN44008 , ZN44009 , ZN44010 , ZN44011 , ZN44012 , ZN44013 , ZN44014 , ZN44015 , ZN44016 , ZN44017 , ZN44018 , ZN44019 , ZN44020 , ZN44021 , ZN44022 , ZN44023 , ZN44024 , ZP01002 , ZP01003 , ZP01004 , ZP01005 , ZP01006 , ZP01007 , ZP01008 , ZP01011 , ZP01012 , ZP01013 , ZP01014 , ZP01015 , ZP01016 , ZP01017 , ZP01018 , ZP01019 , ZP01020 , ZP01021 , ZP01022 , ZP01023 , ZP01024 , ZP01025 , ZP01026 , ZP01027 , ZP01028 , ZP01029 , ZP01030 , ZP01031 , ZP01032 , ZP01033 , ZP01034 , ZP01035 , ZP01036 , ZP01037 , ZP01039 , ZP01041 , ZP01042 , ZP01043 , ZP0I034 , ZP42001 , ZP42002 , ZP42003 , ZP42004 , ZP42005 , ZP42006 , ZP42007 , ZP42008 , ZP42009 , ZP42010 , ZP42011 , ZP42012 , ZP42014 , ZP42015 , ZP42016 , ZP42017 , ZP42018 , ZP42019 , ZP42020 , ZP42021 , ZP42022 , ZR45001 , ZR45002 , ZR45003 , ZR45004 , ZR45005 , ZR45006 , ZR45007 , ZR45008 , ZR45009 , ZR45010 , ZR45011 , ZR45012 , ZR45013 , ZR45014 , ZR45015 , ZR45016 , ZR45017 , ZR45018 , ZR45019 , ZR45020 , ZR45021 , ZR45022 , ZR45023 , ZR45024 , ZR45025 , ZR45026 , ZR48001 , ZR48002 , ZR48003 , ZR48004 , ZR48005 , ZR48006 , ZR48007 , ZR48008 , ZR48009 , ZR48010 , ZR48011 , ZR48012 , ZR48013 , ZR48014 , ZR48015 , ZR48016 , ZR48017 , ZR48018 , ZR48019 , ZR48020 , ZR48021 , ZR48022 , ZS43001 , ZS43002 , ZS43003 , ZS43004 , ZS43005 , ZS43006 , ZS43007 , ZS43008 , ZS43009 , ZS43010 , ZS43011 , ZS43012 , ZS43013 , ZS43014 , ZS43015 , ZS43016 , ZS43017 , ZS43018 , ZS43019 , ZS54002 , ZS54004 , ZS54005 , ZS54006 , ZS54007 , ZS54008 , ZS54009 , ZS54010 , ZS54011 , ZS54012 , ZS54013 , ZS54014 , ZS54015 , ZS54016 , ZS54017 , ZS54019 , ZS54020 , ZS54021 , ZS59001 , ZS59002 , ZS59003 , ZS59004 , ZS59005 , ZS59006 , ZS59007 , ZS59008 , ZS59009 , ZS59010 , ZS59011 , ZS59012 , ZS59013 , ZS59014 , ZS59015 , ZS59016 , ZS59017 , ZS59018 , ZS59019 , ZT18001 , ZT18002 , ZT18003 , ZT18004 , ZT18005 , ZT18006 , ZT18007 , ZT18008 , ZT18009 , ZT18010 , ZT18011 , ZT18012 , ZT18013 , ZT18014 , ZT18015 , ZT18016 , ZT18017 , ZT18018 , ZT18019 , ZT18020 , ZT18021 , ZT18022 , ZT18023 , ZT18024 , ZT18025 , ZT18026 , ZT18027 , ZT18028 , ZT18029 , ZT18030 , ZT18031 , ZT18032 , ZT18033 , ZT18034 , ZT18035 , ZT18036 , ZT18037 , ZT18038 , ZT18039 , ZT18040 , ZT27001 , ZT27002 , ZT27003 , ZT27004 , ZT27005 , ZT27006 , ZT27007 , ZT27008 , ZT27009 , ZT27010 , ZT27011 , ZT27012 , ZT27013 , ZT27014 , ZT27015 , ZT27016 , ZT27017 , ZT27018 , ZT27019 , ZT27020 , ZT27021 , ZT27022 , ZT27023 , ZT27024 , ZU33001 , ZU33002 , ZU33003 , ZU33004 , ZU33005 , ZU33007 , ZU33008 , ZU33009 , ZU33011 , ZU33012 , ZU33013 , ZU33014 , ZU33015 , ZU33016 , ZU33017 , ZU33018 , ZU33019 , ZU33020 , ZU33021 , ZU33022 , ZU33023 , ZU33024 , ZU33025 , ZU33026 , ZU33027 , ZU33029 , ZU33030 , ZU33031 , ZU33032 , ZU33033 , ZU33034 , ZU33035 , ZV29001 , ZV29002 , ZV29003 , ZV29004 , ZV29005 , ZV29006 , ZV29007 , ZV29008 , ZV29009 , ZV29010 , ZV78001 , ZV78002 , ZV78003 , ZV78004 , ZV78006 , ZV78007 , ZV78008 , ZV78009 , ZV78010 , ZV78011 , ZV78012 , ZV78013 , ZV78014 , ZV78015 , ZV78016 , ZV78017 , ZV78018 , ZV78019 , ZV78020 , ZV78021 , ZV78022 , ZW15001 , ZW15002 , ZW15003 , ZW15004 , ZW15005 , ZW15006 , ZW15007 , ZW15008 , ZW15009 , ZW15011 , ZW15012 , ZW15013 , ZW15014 , ZW15015 , ZW15016 , ZW15017 , ZW15018 , ZW15019 , ZW15020 , ZW15021 , ZW15022 , ZW34002 , ZW34003 , ZW34004 , ZW34006 , ZW34007 , ZW34008 , ZW34009 , ZW34010 , ZW34011 , ZW34013 , ZW34015 , ZW34016 , ZW34017 , ZW34018 , ZW34019 , ZW34020 , ZW34021 , ZW34022 , ZW74007 , ZW74008 , ZW74009 , ZW74010 , ZW74011 , ZY49001 , ZY49002 , ZY49003 , ZY49004 , ZY49005 , ZY49006 , ZY49007 , ZY49009 , ZY49011 , ZY49012 , ZY49014 , ZY49016 , ZY49017 , ZY49018 , ZY49019 , ZY49020 , ZY49021 , ZZ02001 , ZZ02002 , ZZ02003 , ZZ02004 , ZZ02005 , ZZ02006 , ZZ02007 , ZZ02008 , ZZ02009 , ZZ02011 , ZZ02012 , ZZ02013 , ZZ02014 , ZZ02015 , ZZ02016 , ZZ02017 , ZZ02018 , ZZ02019 , ZZ02020 , ZZ02021 , ZZ02022 , ZZ02023 , ZZ02024 , ZZ08001 , ZZ08002 , ZZ08003 , ZZ08004 , ZZ08005 , ZZ08006 , ZZ08007 , ZZ08008 , ZZ08009 , ZZ08010 , ZZ08011 , ZZ08012 , ZZ08013 , ZZ08014 , ZZ08015 , ZZ08016 , ZZ08018 , ZZ08019 , ZZ08020 , ZZ08021 , ZZ08022 , ZZ08023 , ZZ69000 , ZZ69003 , ZZ69004 , ZZ69005

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.