Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003...
FDA Device Recall #Z-1092-2026 — Class II — October 9, 2025
Recall Summary
| Recall Number | Z-1092-2026 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 9, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | C-RAD POSITIONING AB |
| Location | Uppsala |
| Product Type | Devices |
| Quantity | 189 |
Product Description
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
Reason for Recall
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.
Distribution Pattern
The software module cSRS has been installed in 37 countries Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, CA, CT, FL, MO, NC, NM, NY, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Australia, Austria, Belarus, Belgium, Benin, Canada, China, Colombia, Egypt, El Salvador, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Mexico, Morocco, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, and Vietnam.
Lot / Code Information
Lot Code: Note: The error is not related to any serial numbers or LOT numbers. The error is limited to the software module cSRS in combination with cMotion module
Other Recalls from C-RAD POSITIONING AB
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1858-2025 | Class II | Brand Name: Catalyst+ Product Name: C4D softwa... | Apr 22, 2025 |
| Z-2075-2021 | Class II | PC Application Software c4D as part of the devi... | Aug 6, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.