Envisiontec US Llc Recall 89534
Description: 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.
Envisiontec US Llc Recall 89534 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0746-2022 |
| Event ID | 89534 |
| Event Description | 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 Type | Devices |
| Distribution | US Nationwide |
| Quantity | 172 units |
| Recall Reason | The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications. |
| Device Classification | 20220316 |
| Device Code Info | All units SKU number ACC-06-1000 |
| Center Classification Date | 20220310 |
| Recall Initiation Date | 20220120 |
| Recalling Firm | Envisiontec US Llc |
| Initial Notification | Letter |
| Similar To |