Recall record at a glance
| Official record | Z-0651-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Midmark Corp dba Progeny Inc. |
| Report date | Feb 3, 2016 |
| Recall initiation date | Sep 4, 2014 |
| Quantity | 832 systems |
| Location | Lincolnshire, IL, United States |
Official product 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
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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