C-RAD POSITIONING AB: 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

Recall number

Z-1092-2026

Recalling firm

C-RAD POSITIONING AB

Product

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

Status

Open, Classified

Initiated

2025-10-09

Posted

2026-01-14

Terminated

not on file

Reason

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.

Root cause

Under Investigation by firm

Action

On 10/14/2025, the firm email an Urgent Field Safety Notice to customers informing them that C-RAD has noted a potential issue affecting the cSRS mode of the Catalyst+ HD and Catalyst HD systems. All software version above c4D 5.3.2 are affected by this issue. The issue is that the stated precision of the Catalyst system for stereotactic radiosurgery (SRS) treatments cannot be guaranteed for all couch angles and system setups. In 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 could in the worst-case result in erroneous dose delivery. This issue affects Catalyst+ HD and Catalyst HD systems, configured for cSRS and cMotion. Customers are instructed to: 1. Ensure that all the staff operating the Catalyst+ HD and Catalyst HD, and the c4D software application are informed of this information. 2. As an immediate action, affected users are advised to not use Catalyst+ HD and Catalyst HD in combination with cSRS and cMotion. C-RAD will release a new version of the software application c4D resolving the issue and/or update IFU/labelling. For questions please contact C-RAD Quality Department as regulatory@c-rad.com

Quantity

189

Distribution

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.

Lot, serial or model codes

Lot Code: Note: 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

510(k) numbers

K200435

PMA numbers

not on file

Product code

IYE

Firm FEI

3006621300

Firm city

Uppsala

Firm state

not on file

Firm country

Sweden

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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