Recall Z-0651-2016— Midmark Corp dba Progeny Inc

Name: FDA recall Z-0651-2016
Creator: U.S. Food and Drug Administration
Published: 2014-09-04

Class II · Terminated

Class II FDA medical device recall by Midmark Corp dba Progeny Inc, initiated 2014-09-04, terminated 2017-12-29. It names one FDA 510(k) clearance: K122643. 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: 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..

Recalling firm: Midmark Corp dba Progeny Inc
Classification: Class II
Status: Terminated
Initiated: 2014-09-04
Terminated: 2017-12-29
Firm location: Lincolnshire, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K122643 — VANTAGE MODEL V5000, V5100, V5000C, V5100CMidmark Corp.·cleared 2013-01-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.