C-RAD POSITIONING AB recalled 189 Catalyst and Catalyst+ devices on October 9, 2025, due to issues with stereotactic radiosurgery (SRS) treatment. The defect may lead to incorrect patient positioning, potentially compromising treatment effectiveness. The recall affects devices distributed across 37 countries, including the United States.
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.
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
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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.
The issue arises from the software module that may incorrectly indicate proper patient positioning, potentially leading to ineffective treatment outcomes.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must cease using the device immediately to avoid potential treatment risks.
Model numbers and software versions can usually be found on the device label or user manual.
Expect a response for refund processing within 4-6 weeks after contacting the manufacturer.
Keep records of your communications with the manufacturer, including dates and 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.
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