SYNGO.VIA (2020-08-24)

Starting date:

August 24, 2020

Posting date:

September 4, 2020

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-73861

Last updated:
2020-09-04

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  Reason
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  Affected products

Affected Products

SYNGO.VIA

Reason

Siemens has identified an incorrect parameter (technical issue) in the laserbridge configuration of syngo.via RT Image Suite, software versions syngo.via VB30 and syngo.via VB40 with licence for patient marking with external lasers (technical name of the licence is "CT RT IMAGE SUITE PAT MARK"). The calibration offset between the central CT image plane and the external RT lasers has been set automatically to the factory default of 50.00 cm. If the syngo.via RT image suite has been updated or upgraded to one of the previously mentioned software versions, and the mis adjustment of the offset value is not recognized during the subsequent treatment planning process or remains undetected during the position verification at the treatment system (e.g. linear accelerator), this can potentially result in an unprecise treatment (dose applied to the wrong location).

Affected products