C-RAD POSITIONING AB recalls Brand Name: Catalyst+ Product Name: Catalyst

Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n 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.

Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not applicable

On 10/14/2025, the firm email an Urgent Field Safety Notice to customers informing them that C-RAD has noted a potential issue affecting the cSRS mode of the Catalyst+ HD and Catalyst HD systems. All software version above c4D 5.3.2 are affected by this issue. 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 worst-case result in erroneous dose delivery. This issue affects Catalyst+ HD and Catalyst HD systems, configured for cSRS and cMotion. Customers are instructed to: 1. Ensure that all the staff operating the Catalyst+ HD and Catalyst HD, and the c4D software application are informed of this information. 2. As an immediate action, affected users are advised to not use Catalyst+ HD and Catalyst HD in combination with cSRS and cMotion. C-RAD will release a new version of the software application c4D resolving the issue and/or update IFU/labelling. For questions please contact C-RAD Quality Department as regulatory@c-rad.com

• FDA enforcement recordOfficial FDA database entry for Z-1092-2026
• FDA 510(k) clearance · K200435The device's official FDA premarket clearance record
• FDA device classification · IYEOfficial FDA classification for this device type
• CFR regulation · 21 CFR 892.5050The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find C-RAD POSITIONING ABSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.