Catalyst, Catalyst+ recalled by C-rad Positioning Ab

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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

Where it was distributed

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.

Nationwide AlaskaAlabamaArkansasCaliforniaConnecticutFloridaMissouriNorth CarolinaNew MexicoNew YorkOhioOklahomaOregonPennsylvaniaTennesseeTexasVirginiaWashington