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