United StatesC-Rad Positioning Ab is recalling the Catalyst/Catalyst+ patient positioning device (model/catalog SP001-0026, SP003-0002) when running the cSRS software module in combination with the cMotion module. The cSRS/cMotion combination can fail for certain couch angles and setups, and the system may indicate the patient is correctly positioned at isocenter even when the isocenter is outside the indicated tolerance, so stereotactic radiosurgery (SRS) treatment cannot be guaranteed.
What's being recalled
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: Not applicable
Recalling firm: C-Rad Positioning Ab, Uppsala, Sweden.
How to identify it
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
The hazard
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 to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
The software module cSRS has been installed in 37 countries Worldwide - U.S. Nationwide distribution in the states of AK, AL, AR, CA, CT, FL, MO, NC, NM, NY, OH, OK, OR, PA, TN, TX, VA, and WA. The countries of Argentina, Australia, Austria, Belarus, Belgium, Benin, Canada, China, Colombia, Egypt, El Salvador, Finland, France, Germany, Greece, Hungary, India, Italy, Japan, Jordan, Mexico, Morocco, Netherlands, New Zealand, Norway, Portugal, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, and Vietnam.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada