Z-1092-2026Class II

Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software...

Name: Z-1092-2026 Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software...
Creator: C-Rad Positioning Ab
Published: 2025-10-09
License: https://open.fda.gov/license/

C-Rad Positioning AB / initiated 2025-10-09 / Open, Classified

FDA source

C-RAD POSITIONING AB began a recall of Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion... on 2025-10-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1092-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-10-09
Posted: 2026-01-14
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
Product code: IYE Accelerator, Linear, Medical
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.
FDA 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 [email protected]
Quantity in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1092-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1092-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-14

Product code IYE

K200435Class IICatalyst+, Catalyst+ HDC-Rad Positioning AB / cleared 2020-05-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)