Device recall
Z-1092-2026: Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number…
FDA device recall · Class II · C-RAD POSITIONING AB
Key facts
| Recall number (Z-number) | Z-1092-2026 |
|---|---|
| Recall event | 97872 |
| 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 |
| Product code | IYE |
| Recalling firm | C-RAD POSITIONING AB |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K200435 |
| FEI number | 3006621300 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database