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Health Canada Medical devices

Artis products

Issued November 12, 2021
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
Hazard description
Inaccurate test or measurement results
What to do
Contact the manufacturer if you need additional information.
Product
Product name
Artis products
Reference
ID
RA-63585