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Health product recall

Merge Orthocase

Starting date:
August 26, 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-60234

Affected Products

Merge Orthocase

Reason

When using the perpendicular line tool there is an option to "snap" the lines together which prevents the perpendicular lines from extending past the straight/base line. While the system default is set to snap the lines together, the actual "snap" function may not occur until the plan is saved, at which time the line end point within 20 pixels of the base line will adjust its location to snap perfectly to the base line. This may adjust the length and corresponding measurement of the perpendicular line when the plan is reopened.

Affected products

Merge Orthocase

Lot or serial number

More than 10 numbers, contact manufacturer.

Model or catalog number

MERGE ORTHOCASE

Companies
Manufacturer
Merge Healthcare Incorporated,
900 Walnut Ridge Drive,
Hartland
53029
Wisconsin
UNITED STATES