FDAApril 22, 2025device
Brand 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...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
What to do
FDA enforcement status: Ongoing
Brands named
c rad positioning ab
UPCs
0735000528002417350005280762173500052807791735000528079317350005280809
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand 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 applicable2025-10-09
- FDAPlatelia Toxo IgM Catalog Number 26211 UDI Code: 03610520005552 The Platelia Toxo IgM assay is a semi-quantitative immunocapture enzyme immunoassay kit for the detection of IgM antibodies to Toxoplasma gondii in human serum, plasma or cord blood specimens.2025-05-30
- 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 Reagent Pack, REF 665-3250, IVD2023-02-21
- FDABioPlex 2200, Anti-CCP Calibrator Set, REF 663-3200, 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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