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IPLAN RT DOSE (2015-06-12)
- Starting date:
- June 12, 2015
- Posting date:
- August 18, 2015
- 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-54678
Affected Products
A. IPLAN RT DOSE
Reason
A frameless SRS patient treatment was planned with BrainLab Iplan RT dose 4.1.3. The plan was intended for treatment of intra-cranial metastatic lesions located in 3 different regions/isocenters. The customer prescribed 100% dose to 99% of the volume to all three PTVS (defined as "hard constraints").
Affected products
A. IPLAN RT DOSE
Lot or serial number
- 8000005931
- 8000022407
- 8000042478
- 8000078351
- 8000085563
- 8000101538
- 8000101548
- 8000105168
Model or catalog number
21213G
Companies
- Manufacturer
-
Brainlab AG
Kapellenstr. 12
Feldkirchen
85622
GERMANY