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Health product recall

BRAINSCAN RADIOSURGERY SYSTEM - SOFTWARE (2015-11-05)

Starting date:
November 5, 2015
Posting date:
January 14, 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-56594

Affected Products

A. BRAINSCAN RADIOSURGERY SYSTEM - SOFTWARE

Reason

Large objects with fine resolution are potentially displayed cropped when imported into Brainlab Brain Metastases 1.0.0 or Adaptive Hybrid Surgery Analysis 1.0.0.

Affected products

A. BRAINSCAN RADIOSURGERY SYSTEM - SOFTWARE

Lot or serial number

Version 1.0.0

Model or catalog number
  • 21702-04
  • 21703-01
  • 21703-02
Companies
Manufacturer
Brainlab AG
Kapellenstr 12
Feldkirchen
85622
GERMANY