Z-0651-2016Class II

Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage...

Name: Z-0651-2016 Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage...
Creator: Midmark Corp dba Progeny Inc
Published: 2014-09-04
License: https://open.fda.gov/license/

Midmark Corp dba Progeny Inc / initiated 2014-09-04 / Terminated / root cause: design

FDA source

Midmark Corp dba Progeny Inc began a recall of 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... on 2014-09-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0651-2016
Classification: Class II
Status: Terminated
Initiated: 2014-09-04
Posted: 2016-01-25
Terminated: 2017-12-29
Recalling firm: Midmark Corp dba Progeny Inc
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
Product code: MUH System, X-Ray, Extraoral Source, Digital
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.
Root cause tag: design
FDA root cause: Device Design
Action: MidMark sent an Urgent Medical Device Field Correction letter dated September 4, 2014, to all affected customers. The letter included instructions for distributors to: 1) encourage end users to contact Midmark to arrange the field correction after the final solution becomes available; 2) if a partial image is reported to have occurred with a machine, the machine should be removed from use and the end user should initiate a service request per the normal procedure; 3) quarantine any affected machines in the distributor's inventory and contact Midmark Technical Support within 10 business days to provide the Serial numbers to on-site servicing of the affected machines can be scheduled. Distributors with questions about this market action can contact Midmark Technical Support by calling 888-294-3800 x 3 or by e-mail at [email protected].
Quantity in commerce: 832 systems
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.
Product codes and lots: 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 , 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Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0651-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0651-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-03	2016-01-25

Product code MUH

K122643Class IIVantage Model V5000, V5100, V5000c, V5100cMidmark Corp. / cleared 2013-01-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)