Brand Name: Catalyst+ Product Name: C4D software used in conjunction… — Class II medical device recall Z-1858-2025
Ongoing recall by C-RAD POSITIONING AB, reported 2025-06-04, distributed nationwide. Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
| Recall number | Z-1858-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C-RAD POSITIONING AB, Uppsala, N/A, Sweden |
| Recall initiated | 2025-04-22 |
| Classified | 2025-05-28 |
| Reported by FDA | 2025-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CN, DE, EE, IT, KR, VN |
| Quantity | 44 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07350005280024, 17350005280762, 17350005280779, 17350005280793, 17350005280809 |
| Model numbers | SP003-0001, SP003-0002, SP003-0008, SP003-0009 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1858-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.