Brand Name: Catalyst+ Product Name: Catalyst — Class II medical device recall Z-1092-2026
Ongoing recall by C-RAD POSITIONING AB, reported 2026-01-21, distributed nationwide. Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch a
| Recall number | Z-1092-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | C-RAD POSITIONING AB, Uppsala, Sweden |
| Recall initiated | 2025-10-09 |
| Classified | 2026-01-14 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AT, AU, BE, CA, CH, CN, CO, DE, EG, ES, FI, FR, GR, HU, IN, IT, JO, JP, KR, MA, MX, NL, NO, NZ, PT, RO, RU, SE, SG, SV, TW, UA, VN |
| Quantity | 189 |
| Model numbers | SP001-0026, SP003-0002 |
Product
Brand 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 applicable
Reason for recall
Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed for all couch angles and system setups. n certain cases, the system may indicate the patient as correctly positioned at the isocenter, even when the isocenter is positioned outside of the indicated tolerance.
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-1092-2026. 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.