C-RAD POSITIONING AB: Device Recall

Recall #Z-1092-2026 · 10/09/2025

Class II: Risk

Recall Details

Recall Number
Z-1092-2026
Classification
Class II
Product Type
Device
Recalling Firm
C-RAD POSITIONING AB
Status
Ongoing
Date Initiated
10/09/2025
Location
Uppsala, Sweden
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
189

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.

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

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.

Other Recalls by C-RAD POSITIONING AB

View all recalls by C-RAD POSITIONING AB →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.