Health product recall

Artis products

Last updated

Summary

Product
Artis products
Issue
Medical devices - Inaccurate test or measurement results
What to do

Contact the manufacturer if you need additional information.

Affected products

Affected Products Lot or serial number Model or catalog number
ARTIS PHENO Version VE20C 10849000
ARTIS ICONO BIPLANE Serial # 180324 11327600
ARTIS ICONO FLOOR Version VE20C 11327700

Issue

Issue 1 - updated calibration data not saved with measurement after scene+/- :
after closing and reopening the same scene during review, the previously displayed change of distance measurements is lost, i.E. The image text shows the updated calibration factor although it was not applied to the distance measurement values.
Issue 2 - no X-ray possible, system shutdown/restart might be required during intervention: in very rare cases a regular operation of the system might not be possible any more due to a software error in the image visualization system (IVS). However, "Bypass Fluoroscopy" mode is still available.
Issue 3 - corrupted image during roadmap: after using the zoom out functionality during dsa roadmap (DSA RDMP), the subsequent roadmap might potentially be corrupted.
Issue 4 - unintended shutdown of imaging system with UPS (Uninterruptable Power Supply) option (only for customer with UPS who are already informed with CSAN AX019/21/s are affected): in very rare cases the imaging system UPS sporadically forces a shutdown of the imaging system PC without a true power supply problem. After implementation of the measure AX020/21/s the UPS is disconnected and the issue cannot occur.

Recall start date: 2021-10-14

What you should do

Contact the manufacturer if you need additional information.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Radiology
Companies

SIEMENS HEALTHCARE GMBH

HENKESTR. 127, ERLANGEN

GERMANY

 
Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63585