Health product recall

syngo.via (2019-03-23)

Starting date:
March 23, 2019
Posting date:
April 16, 2019
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-69616

Last updated: 2019-04-16

Affected Products

syngo.via

Reason

Siemens is notifying users of a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure using syngo.ct cardiac function or syngo.ct cardiac planning in syngo.via. This risk is due to a software issue found in the TAVI algorithm. During the automatic procedure a smoothing algorithm subsequently adjusts the shape of the centerline. In unfavourable conditions this smoothing algorithm can result in a slight distortion of the centerline and ultimately in a tilting of the measurement plane compared to the previously defined annulus plane. Any measurements of annular parameters taken under the described conditions might be incorrect due to the tilted measurement plane. The magnitude of the deviation depends on the initial shape of the individual centerline related to the patient's anatomy. The stronger the initial bend in the centerline, the stronger the correction level of the smoothing operation.

Affected products

syngo.via

Lot or serial number

Not applicable.

Model or catalog number

10496180

Companies
Manufacturer

Siemens Healthcare GmbH

Henkestr. 127

Erlangen

91052

GERMANY