Health product recall

Kick Navigation System (2020-07-17)

Starting date:
July 17, 2020
Posting date:
July 24, 2020
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-73605

Last updated: 2020-07-24

Affected Products

Kick Navigation System

Reason

Specific NDI Polaris Spectra Cameras installed on Brainlab Curve and Kick Navigation Systems were delivered with an incorrect manufacturer calibration, affecting the use of active marker registration instruments with the navigation system, especially relevant for the Z-touch Laser Pointer patient registration with Cranial or ENT navigation software.

Affected products

Kick Navigation System

Lot or serial number

S/N: 2933119001-18170

Model or catalog number

18170

Companies
Manufacturer
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY