Health product recall

Catalyst Hd and Catalyst+ Hd Systems

Last updated

Summary

Product
Catalyst Hd and Catalyst+ Hd Systems
Issue
Medical devices - Performance
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

Catalyst HD

All lots.

SP001-0026

Catalyst+ HD

All lots.

SP003-0002

Issue

C-RAD has noted a potential issue affecting the CSRs mode of the Catalyst+ HD and Catalyst HD systems. The issue is that the stated precision of the catalyst system for stereotactic radiosurgery (SRS) treatments cannot be guaranteed for all couch angles and system setups. in certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance. This could in the worstcase result in erroneous dose delivery.

Additional information

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

C-RAD Positioning AB

Sjukhusvagen 12k, Uppsala, Sweden, 75309

Published by
Health Canada
Audience
Healthcare
Recall class
Type I
Recall date
Identification number
RA-78329

Get notified

Receive emails about new and updated recall and safety alerts.

Subscribe