Patient positioning systems recalled over stereotactic radiosurgery tolerance errors
C-RAD Positioning is recalling 189 Catalyst and Catalyst+ systems because the system may indicate a patient as correctly positioned at the isocenter when it is outside tolerance.
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: Scored 3 under the risk-of-harm criterion: the firm states the system may report correct positioning when the isocenter is outside tolerance during radiosurgery, and no injuries are reported.
Plain-English summary
The C-RAD Catalyst and Catalyst+ patient positioning devices, model numbers SP001-0026 and SP003-0002, running the cSRS module in combination with the cMotion module, are being recalled by C-RAD Positioning AB.
The record states that due to issues with the system, stereotactic radiosurgery treatment cannot be guaranteed for all couch angles and system setups, and that in 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.
The record lists 189 units and notes that the error is not related to any serial or lot numbers but is limited to the software. The cSRS software module has been installed in 37 countries, with distribution worldwide including nationwide in the United States. The FDA has classified the action as Class II.
The enforcement record reports no injuries. Sites should follow C-RAD's instructions.
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
- Hazard
- positioning-error
- software-fault
- radiosurgery
- isocenter-tolerance
Distribution
Distributed nationwide across the United States.
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