FDA-Device2026-01-21Class IIPROCESSING DEFECT

C-RAD Catalyst+ patient positioning system recalled for stereotactic radiosurgery positioning errors

OTHERNationwide distributionMedical devices

What this means

The Catalyst+ patient positioning system used in stereotactic radiosurgery (a type of radiation therapy) has a software issue that may cause incorrect patient positioning. In some cases, the system may show a patient is correctly positioned when they are actually outside the safe treatment area, which could affect treatment accuracy.

Contact C-RAD POSITIONING AB or your equipment representative immediately to discuss the software issue
Do not rely on the system's positioning confirmation alone until the issue is resolved
Ask your facility about available updates or workarounds from the manufacturer
Review recent patient treatments with your clinical team if you use the cSRS and cMotion modules

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The agency's original wording

Hazard

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.

Intended for

Adults

Illnesses reported

None reported

Sold states

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.

Affected count

189

Manufactured in

Bredgrand 18, Uppsala, Sweden

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1092-2026

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