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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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

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