Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage…
Medical device recall Z-0651-2016. Published in FDA’s Enforcement Report on Feb 3, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Feb 3, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 34 states named in where it went
- 832 systems how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
832 systems, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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 ,…
Every code shown here, 1,994 characters
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 ,…
FDA’s list runs to 8,331 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
The states and territories these words name
34 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Iowa
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Michigan
- Minnesota
- Missouri
- Mississippi
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Pennsylvania
- South Carolina
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 4, 2014.
- FDA classified it on Jan 25, 2016.
- FDA’s Enforcement Report published it on Feb 3, 2016.
- FDA terminated it on Dec 29, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Midmark Corp dba Progeny Inc, of Lincolnshire, IL.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 8,331 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.