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 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.
The device may not guarantee accurate SRS treatment at all couch angles and setups. In some cases, it may indicate correct patient positioning even when the isocenter is outside of the indicated tolerance.
There are no specific reports of injuries or incidents resulting from this recall. The potential risk associated with incorrect patient positioning remains high.
Stop using the device immediately. Follow the manufacturer's recall instructions and contact C-RAD POSITIONING AB or your healthcare provider for further instructions.
For assistance, contact C-RAD POSITIONING AB. Visit their official website or refer to the recall notice at the FDA link provided.
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