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Health product recall

Merge Eye Station

Starting date:
December 19, 2016
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-61484

Reason

This recall has been initiated due to an issue related to the potential accidental deletion of record(s) by an eye station user.  In the current workflow, a user can select to delete a record(s).  When that selection is made, a confirmation box is presented asking the user if they want to delete the record(s). The user can then either left click on "ok" or press the "enter" key to confirm the action. Currently, this confirmation defaults to "ok" or "yes". In this workflow, a user could inadvertently hit the "enter" key, which would delete the images or procedures. Once these images or procedures are deleted, they are lost permanently with no recovery.

Affected products

Merge Eye Station

Lot or serial number

  • 10.6
  • 11.2.0
  • 11.2.1
  • 11.3.0
  • 11.3.1
  • 11.3.2
  • 11.4
  • 11.5
  • 11.6.0

Model or catalog number

MERGE EYE STATION

Companies

Manufacturer

Merge Healthcare Incorporated,

900 Walnut Ridge Drive,

Hartland

53029

Wisconsin

UNITED STATES