Patient positioning system software may fail to detect stereotactic radiosurgery positioning errors
C-RAD Catalyst and Catalyst+ patient positioning systems for stereotactic radiosurgery may incorrectly indicate proper patient positioning, potentially compromising radiation treatment accuracy. Approximately 189 units have been distributed in 37 countries including the United States.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II medical device for stereotactic radiosurgery carries inherent risk of treatment inaccuracy if positioning is incorrectly indicated, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.' No hospitalizations or illnesses have been reported.
Plain-English summary
The Catalyst and Catalyst+ patient positioning systems, specifically the cSRS (stereotactic radiosurgery) software module used in combination with the cMotion module, are subject to this recall. These systems are used for diagnostic imaging and radiotherapy, with model numbers SP001-0026 and SP003-0002.
The cSRS software module contains a defect that prevents stereotactic radiosurgery treatment from being properly guaranteed across all couch angles and system setups. In certain cases, the system may incorrectly indicate that the patient is properly positioned at the isocenter when the isocenter is actually positioned outside the indicated tolerance zone. This positioning error could result in the delivery of radiation treatment to an incorrect anatomical location.
Approximately 189 systems containing the affected software module have been distributed in 37 countries worldwide, including 18 US states: Alaska, Alabama, Arkansas, California, Connecticut, Florida, Missouri, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Virginia, and Washington.
The recalled product
- 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
- Manufacturer
- C-RAD POSITIONING AB
- Category
- Medical Device — Radiotherapy
- Hazard
- positioning-error
- treatment-inaccuracy
Distribution
Distributed nationwide across the United States.
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