C-RAD Catalyst positioning devices with specific models may misposition patients during stereotactic radiosurgery, risking treatment failure. Affected units include SP001-0026 and SP003-0002 models. Contact C-RAD for details.
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.
C-RAD's Catalyst positioning devices with models SP001-0026 and SP003-0002 may misposition patients during stereotactic radiosurgery, potentially causing treatment failure. This recall affects medical devices used in radiation therapy settings.
The system may show a patient as correctly positioned when they're actually outside the required tolerance, which could lead to treatment failure. This error occurs only with specific software combinations (cSRS and cMotion modules) and isn't related to serial numbers or lot codes.
Medical facilities using C-RAD Catalyst positioning devices with models SP001-0026 and SP003-0002 for stereotactic radiosurgery are most at risk. Patients undergoing radiation treatment with these devices could experience inaccurate positioning.
Check for models SP001-0026 or SP003-0002 on the device. The error is limited to the software modules cSRS and cMotion, not serial numbers or lot numbers.
Confirm the device uses both cSRS and cMotion software modules, as the error is specific to this combination.
No, but you should verify the software modules. The recall does not require immediate discontinuation.
No, the error is not related to serial numbers or lot numbers.
Contact C-RAD directly for guidance on verifying the software modules and potential next steps.
We’ve drafted a message you can send C-RAD to request your refund or repair — edit it as you like.
Subject: Recall Z-1092-2026 — C-RAD C-RAD Hello, I own a C-RAD that is covered by recall Z-1092-2026 from C-RAD. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
