RT Elements - Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA (2019-03-26)
- Starting date:
- March 26, 2019
- Posting date:
- May 3, 2019
- 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-69804
Last updated: 2019-05-03
Affected Products
A. RT Elements - Multiple Brain Mets SRS
B. RT Elements - Cranial SRS
C. RT Elements - Spine SRS
D. RT Elements - RT QA
Reason
Potentially incorrect dose distribution calculation by Brainlab RT Elements software (for affected versions, see above) under specific circumstances when using the Pencil Beam algorithm on the GPU (graphics card), as is the default system setting.
Affected products
A. RT Elements - Multiple Brain Mets SRS
Lot or serial number
6705318001
8031719001
Model or catalog number
MULTIPLE BRAIN METS SRS 1.5
Companies
- Manufacturer
-
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY
B. RT Elements - Cranial SRS
Lot or serial number
6708118001
8033819001
Model or catalog number
CRANIAL SRS1.0
CRANIAL SRS1.5
Companies
- Manufacturer
-
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY
C. RT Elements - Spine SRS
Lot or serial number
8034719001
Model or catalog number
SPINE SRS1.0
SPINE SRS1.5
Companies
- Manufacturer
-
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY
D. RT Elements - RT QA
Lot or serial number
6709418001
8035419001
Model or catalog number
RT QA1.0
RT QA1.5
Companies
- Manufacturer
-
BrainLab AG
Olof-Palme-Strasse 9
Munich
81829
GERMANY