FDAOctober 9, 2025device
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
Official recall recorded by the U.S. Food & Drug Administration.
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
FDA enforcement status: Ongoing
Brands named
c rad positioning ab
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- FDABrand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Catalyst+ X4, (SPOO3-0009) Product Descripti...2025-04-22
- FDABio-Rad, REF: 12005660, QXDx BCR-ABL %IS Kit2024-02-15
- FDABioPlex 2200 REF 665-2050, APLS IgM Pack, APLS IgM Reagent Pack2023-02-28
- FDABioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, IVD2023-02-21
- FDABioPlex 2200, Anti-CCP Reagent Pack, REF 665-3250, IVD2023-02-21
- CPSCRad Power Bikes Recalls RadWagon 4 Electric Cargo Bikes Due to Fall and Crash Hazards (Recall Alert)2022-11-03
- FDACMV IgM EIA, in vitro diagnostic.2022-10-19
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