Device recall
Z-1858-2025: Brand Name: Catalyst+ Product Name: C4D software used in conjunction with…
FDA device recall · Class II · C-RAD POSITIONING AB
Key facts
| Recall number (Z-number) | Z-1858-2025 |
|---|---|
| Recall event | 96791 |
| 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… |
| 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