Quick Facts at a Glance
- Recall Date
- October 9, 2025
- Hazard Level
- HIGH
- Brand
- C-RAD POSITIONING AB
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- C-RAD POSITIONING AB
- Product type
- Patient Positioning Device
- Model 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
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 9, 2025
Reported by FDA DEVICE
January 21, 2026
RecallRadar source check
January 28, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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 You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact C-RAD POSITIONING AB or your healthcare provider for instructions. Notification method: Letter
About This Product
The Catalyst and Catalyst+ devices are used for patient positioning in diagnostic imaging and radiotherapy, particularly in stereotactic radiosurgery. They help ensure accurate targeting during treatment.
Why This Is Dangerous
The issue arises from the software module that may incorrectly indicate proper patient positioning, potentially leading to ineffective treatment outcomes.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must cease using the device immediately to avoid potential treatment risks.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device for SP001-0026 or SP003-0002.
- Confirm the presence of the cSRS software module in combination with cMotion module.
- Consult healthcare provider for guidance on affected devices.
Where to find product info
Model numbers and software versions can usually be found on the device label or user manual.
What timeline to expect
Expect a response for refund processing within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Follow up with C-RAD POSITIONING AB via phone or email.
- Consider contacting regulatory authorities if issues persist.
How to prevent similar issues
- Research safety certifications for medical devices before purchase.
- Consult healthcare professionals for device recommendations.
- Stay informed about product recalls in the medical device sector.
Documentation advice
Keep records of your communications with the manufacturer, including dates and details.
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Product Details
The recalled models are Catalyst (SP001-0026) and Catalyst+ (SP003-0002). These devices include the cSRS module used in combination with the cMotion module. The devices were distributed across 37 countries, including the U.S. states of AK, AL, AR, CA, CT, FL, MO, NC, NM, NY, OH, OK, OR, PA, TN, TX, VA, and WA.
Key Facts
- Recall date: October 9, 2025
- Quantity recalled: 189 units
- Hazard classification: Class II
- Risk level: High
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Safety Guide
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