Class II — C-RAD POSITIONING AB
| Recalling firm | C-RAD Positioning AB |
|---|---|
| Registered facility | C-RAD POSITIONING AB (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Quantity | 44 units |
| 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. |
| Initiated | 2025-04-22 |
| Classified | 2025-05-28 |
| Recall number | Z-1858-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — C-RAD POSITIONING AB (Z-1858-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96791/
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