Recall Weekly← all recalls
FDA-Device2026-01-21Class IIPROCESSING DEFECT

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

C-RAD
OTHERNationwide distribution

Check C-RAD Catalyst+ positioning system software

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
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.

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

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief