This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
Brainscan Radiosurgery System - Software (2015-12-15)
- Starting date:
- December 15, 2015
- Posting date:
- February 1, 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-56890
Affected Products
- BRAINSCAN RADIOSURGERY SYSTEM - SOFTWARE
Reason
The contours of anatomical structures outlined in Brainlab SmartBrush are displayed shifted when loaded in Brain Metastases. Brainlab has identified a potential error when importing image sets and associated outlined objects into Brain Metastases version 1.0.0 or Adaptive Hybrid Surgery analysis version 1.0.0.
Affected products
-
BRAINSCAN RADIOSURGERY SYSTEM - SOFTWARE
Lot or serial number
- 1.0.0.
Model or catalog number
- 21702-04
- 21703-01
- 21703-02
Companies
- Manufacturer
-
Brainlab AG
Kapellenstr 12
Feldkirchen
85622
GERMANY