Events

Recall of PROGENY VANTAGE PANORAMIC X-RAY SYSTEM WITH CEPHALOMETRIC

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MIDMARK CORPORATION.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    103627
  • Event Risk Class
    II
  • Event Initiated Date
    2013-10-11
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    This field action is being initiated to correct a recently identified real time controller (rtc)firmware error found in firmware versions 3.0 3.1 3.2 and 3.3. this error may cause the column of the vantage panoramic x-ray unit to continue moving vertically despite the release of the movement control button (i.E. "failure to stop"). if this occurs while a patient is positioned under the column there is the potential for injury such as bruising sprains or resulting from quick movements to avoid the moving column.

Device

PROGENY VANTAGE PANORAMIC X-RAY SYSTEM WITH CEPHALOMETRIC
  • Model / Serial
    Model Catalog: V5000C (Lot serial: S/N: ZN44018)
  • Product Description
    PROGENY VANTAGE PANORAMIC X-RAY SYSTEM WITH CEPHALOMETRIC
  • Manufacturer
    MIDMARK CORPORATION

Manufacturer

MIDMARK CORPORATION