Reported Jan 21, 2026 · Ongoing
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version:…
C-Rad Positioning Ab
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: C-RAD POSITIONING AB · Bredgrand 18 · Uppsala · N/A
Is this the product you have?
- Brand NameCatalyst+
- Product NameCatalyst, Catalyst+
- Model/Catalog NumberSP001-0026
- SP003-0002 Software VersioncSRS module in combination
- with cMotion module Product DescriptionGMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy
- laser ComponentNot applicable
- Lot codes and dates
- Lot CodeNote: 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
- Amount recalled
- 189
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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