Midmark Corp dba Progeny Inc recalls Vantage Panoramic X-Ray System used to perform dental and orthodontic radiological imaging The Vantage Panoramic X-Ra

Recalled February 3, 2016 · FDA recall Z-0651-2016 · Midmark Corp

Hazard

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 Class II

Units

832 systems

Sold at

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.

Description

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

Manufacturer(s)

Midmark Corp dba Progeny Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →