Health product recall

Artis Icono Biplane

Last updated

Summary

Product
Artis Icono Biplane
Issue
Medical devices - Software defect
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or Serial Number

Model or catalog number

Artis Icono Biplane

Not applicable.

10849000

Artis Icono Biplane

180415

11327600

Artis Icono Floor

170369

11327700

Issue

Issue 1 - Indication of block movements function:
When the operator activates the functions "block movements" or "block table movements" by pressing the block movements button on the pilot control module, there will be a dedicated message displayed on the monitor (e.g. "movement manually disabled - deselect 'block movement"'). However, this message will be displayed for a limited time and will not re-appear when the operator attempts to initiate system movements again.

Issue 2 - Blocked table/stand movement in case of broken drive connection:
In case of a broken drive connection of the table the recovery procedures described in the user manual are not working sufficiently. In case of a broken drive connection a drive error occurs impacting one axis of the siemens table (e.g. tilt or lift). This means the table movement will be blocked entirely, i.e. the desired level of residual functionality will not be maintained. Also, if a drive error impacts one axis of the plane a stand, the stand movement will also be blocked entirely, i.e. the desired level of residual functionality will not be maintained.

Issue 3 - 3D run with manually rotated flat detector:
In case it is intended to perform a 3D acquisition and the flat detector (FD) of plane B is pushed out of its position after the test run before the fast 3d acquisition, e.g. by hand, the 3D run will be performed with a non-defined rotated FD of plane B.

Issue 4 - Stopped and blocked system movements on the Artis Pheno System:
In special, clinically untypical positions of the Artis Pheno stand the robot may move into a so called singularity position, where the movement may get stopped and blocked.

Issue 5 - Missing movement stop with multiple collision sensor activation:
In case of a failure in the collision sensor circuit (e.g. a permanently activated collision protection sensor) between the Artis Pheno and a TrumpF/Maquet table, which occurs rarely, the table movement may not be stopped when another collision sensor gets activated during a table movement.

Recall start date: Apr 28, 2022

Additional information

Details
Original published date: 2022-05-12
Alert / recall type
Health product recall
Category
Health product - Medical device - Radiology
Companies

Siemens Healthcare Gmbh

Henkestr. 127, Erlangen

Germany, 91052

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-64152