Recall Z-0651-2016 ยท MUH System, X-Ray, Extraoral Source, Digital
Midmark Corp dba Progeny Inc
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 examina
| Date | Sep 4, 2014 |
| 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. |
| Root cause | Device Design |
| Action | MidMark sent an Urgent Medical Device Field Correction letter dated September 4, 2014, to all affected customers. The letter included instructions for distributors to: 1) encourage end users to contact Midmark to arrange the field correction after the final solution becomes available; 2) if a partial image is reported to have occurred with a machine, the machine should be removed from use and the end user should initiate a service request per the normal procedure; 3) quarantine any affected machines in the distributor's inventory and contact Midmark Technical Support within 10 business days t |
| 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, Sa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122643 | VANTAGE MODEL V5000, V5100, V5000C, V5100C Midmark Corp., Jan 7, 2013 |