IMPAX (2015-11-20)

Starting date:

November 20, 2015

Posting date:

December 23, 2015

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-56418

• Reason
• Affected products

Recalled Products

A. IMPAX

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.

Affected products