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Health product recall

Brainscan Radiosurgery System-Software and iPlan RT Dose ( 2014-11-19)

Starting date:
November 19, 2014
Posting date:
December 18, 2014
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-42951

A) Brainscan Radiosurgery System-Software
B) iPlan RT Dose

Reason

iPlan RT radiation treatment planning software potentially incorrect patient positioning when using multiple localized CT image data sets.

Affected products

A) Brainscan Radiosurgery System-Software

Lot or serial number

Not applicable

Model or catalog number

70213

Companies

Manufacturer
BrainLab AG
Kapellenstr. 12,
Feldkirchen
85622
GERMANY

B) iPlan RT Dose

Lot or serial number

Not applicable

Model or catalog number

70440A

Companies

Manufacturer
BrainLab AG
Kapellenstr. 12,
Feldkirchen
85622
GERMANY