Events

Recall of IMPAX

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

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
    93577
  • Event Risk Class
    II
  • Event Initiated Date
    2015-11-25
  • 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
    When using the extended addendum workflow in impax 6.5.X and above with embedded reporting there is potential for loss of report text when validating addendums. this occurs when all of the conditions listed below happen at the same time: - the dictation or report text is not started as intended at the initial cursor location and - the keyboard arrow keys mouse or speechmike input are used to move the cursor in the addendum before dictating or typing report text and - the "reportstatus" bookmark is used to automatically add the status to the addendum and - with respect to impax 6.5.4 and prior 6.5.X versions the "beginprotect" and "endprotect" bookmarks have not been used to protect the "reportstatus" bookmark. if all of the above conditions are met and the cursor is placed at the "reportstatus" bookmark location when starting to dictate or type report text impax will overwrite the text entered at the "reportstatus" bookmark location with the addendum status when the addendum is validated. as a result some of the text of the addendum is not saved in the validated addendum.

Device

IMPAX
  • Model / Serial
    Model Catalog: 6.X (Lot serial: IMPAX 6.5.x and above)
  • Product Description
    IMPAX
  • Manufacturer
    AGFA HEALTHCARE INC.

Manufacturer

AGFA HEALTHCARE INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Agfa-Gevaert NV
  • Source
    HC