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Brainscan Radiosurgery Systems (2016-11-23)
- Starting date:
- November 23, 2016
- Posting date:
- March 16, 2017
- 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-62628
Affected Products
A. Brainscan Radiosurgery System - iPlan RT Dose 3.0 Platform Software
B. Brainscan Radiosurgery System - Software
C. Brainscan Radiosurgery System - Head Ring
D. iPlan RT Dose
Reason
Brainlab Radiation Treatment Planning Software: Potential inaccurate dose calculation for small multileaf collimator(MLC)-shaped fields when using the pencil beam algorithm.
Affected products
A. Brainscan Radiosurgery System - iPlan RT Dose 3.0 Platform Software
Lot or serial number
IPLAN RT DOSE 3.0
Model or catalog number
21213
Companies
- Manufacturer
-
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY
B. Brainscan Radiosurgery System - Software
Lot or serial number
BRAINSCAN PLATFORM SW 5.31
BRAINSCAN PLATFORM SW 5.32
Model or catalog number
20140B (5.31)
20140C
Companies
- Manufacturer
-
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY
C. Brainscan Radiosurgery System - Head Ring
Lot or serial number
BRAINSCAN HARDWARE
Model or catalog number
40951-1
Companies
- Manufacturer
-
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY
D. iPlan RT Dose
Lot or serial number
iPlan RT Dose 4.1.1
iPlan RT Dose 4.1.3
iPlan RT Dose 4.1.4
iPlan RT Dose 4.5.1
iPlan RT Dose 4.5.4
Model or catalog number
21213E
21213G
21213H
21381A
21381D
Companies
- Manufacturer
-
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY