CanadaC-RAD Positioning AB’s Catalyst HD (model SP001-0026) and Catalyst+ HD (model SP003-0002), all lots/serial numbers, are affected. The CSR mode’s stated precision for stereotactic radiosurgery (SRS) cannot be guaranteed for all couch angles and system setups and may indicate the patient is at isocenter when they are outside the indicated tolerance, which could result in erroneous dose delivery. Contact the manufacturer for additional information.
What's being recalled
Companies: C-RAD Positioning AB, Sjukhusvagen 12k, Uppsala, Sweden, 75309.
How to identify it
Affected products: Catalyst HD; Lot or serial number: All lots.; Model or catalogue number: SP001-0026
Affected products: Catalyst+ HD; Lot or serial number: All lots.; Model or catalogue number: SP003-0002
The hazard
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States