Vantage Panoramic X-Ray System used to perform dental and orthodontic… — Class II medical device recall Z-0651-2016
Terminated recall by Midmark Corp dba Progeny Inc, reported 2016-02-03, distributed in AL, AR, AZ, CO, CT, DE, FL, GA…. Failure of the primary collimator may result in unintentional movement of the device. The unintentional moveme
| Recall number | Z-0651-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Midmark Corp dba Progeny Inc, Lincolnshire, IL, United States |
| Recall initiated | 2014-09-04 |
| Classified | 2016-01-25 |
| Reported by FDA | 2016-02-03 |
| Terminated | 2017-12-29 |
| Distributed | 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 |
| Countries outside the US | AE, AU, BE, CA, CH, CZ, FR, GB, HU, LT, NZ, PL, RU, SA, TR, VN, ZA |
| Quantity | 832 systems |
| Model numbers | 60-A0001 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0651-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.