FDA Medical devices recall ·
Catalyst+ Product Name: Catalyst, Catalyst+ Model recall
- Recall number
- Z-1092-2026
- Date
- (initiated October 9, 2025)
- Company / brand
- C-Rad Positioning Ab
Bredgrand 18, Uppsala, Sweden - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 189
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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
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.
States: Alaska Alabama Arkansas California Connecticut Florida Missouri North Carolina New Mexico New York Ohio Oklahoma Oregon Pennsylvania Tennessee Texas Virginia Washington
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1092-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.