Device recall
Z-0746-2022: PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing…
FDA device recall · Class II · Envisiontec US Llc
Key facts
| Recall number (Z-number) | Z-0746-2022 |
|---|---|
| Recall event | 89534 |
| Product | PCA 4000 Curing Units, SKU number ACC-06-1000 The PCA 4000 is used for curing industrial resins as well and this recall will not impact units sold to industrial customers. |
| Product code | EBZ |
| Recalling firm | Envisiontec US Llc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K201173 |
| FEI number | 3009261582 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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