FDA Enforcement Class II Terminated

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

Recall: Z-0651-2016 · Reported February 3, 2016

Enforcement

Recall Number
Z-0651-2016
Event ID
70765
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Midmark Corp dba Progeny Inc
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
February 3, 2016
Initiation Date
September 4, 2014
Classification Date
January 25, 2016
Termination Date
December 29, 2017
Address
675 Heathrow Dr, N/A, Lincolnshire, IL, 60069-4206, United States

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

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 Info

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

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.

Quantity

832 systems