FDA recall Z-1858-2025

C-RAD POSITIONING AB · Class II · device

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

Reason for recall

Software issue with scanning equipment that can results in the filed rotation not being applied correctly.

Distribution

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.

Key facts

Status
Ongoing
Initiation date
2025-04-22
Report date
2025-06-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Uppsala, N/A, Sweden

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1858-2025