Ultrasound Integration Software for Cranial/ENT Navigation 3.1.x (2020-08-31)

Starting date:

August 31, 2020

Posting date:

July 29, 2021

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-76095

Last updated:
2021-07-30

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  Reason
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  Affected products

Affected Products 

Ultrasound Integration Software for Cranial/ENT Navigation 3.1.x

Reason

The intraoperative Brainlab Ultrasound Navigation Software does not support the modification of the probe's image width, an optional feature of the BK Medical Ultrasound System, resulting in an incorrect display of the depth of the ultrasound overlay by the navigation for non-linear ultrasound probes, with the deviation depending on the probe and the difference between the calibrated and used image width.

Affected products