Class II — Midmark Corp dba Progeny Inc
| Recalling firm | MIDMARK CORP. |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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 |
| Quantity | 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. |
| Initiated | 2014-09-04 |
| Classified | 2016-01-25 |
| Terminated | 2017-12-29 |
| Recall number | Z-0651-2016 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Midmark Corp dba Progeny Inc (Z-0651-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70765/
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