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C-RAD POSITIONING AB recalls Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (
Recalled June 4, 2025 · FDA recall Z-1858-2025 · C-RAD POSITIONING AB
Hazard
Software issue with scanning equipment that can results in the filed rotation not being applied correctly. · FDA Class II
Units
44 units
Sold at
Worldwide - US Nationwide distribution in the states of AK, FL, WA, VA, WA, NC, IL, AR, NC and the countries of Germany, Italy, Uzbekistan, South Korea, Vietnam, Austria, Australia, China, Estonia, Belgium, Uzbekistan.
Description
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Product
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 Description: Patient positioning device, diagnostic imaging/radiotherapy, laser Component: Not a component
Manufacturer(s)
C-RAD POSITIONING AB
Made in
Sweden
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →