Device 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.
Z-0746-2022
Product summary
- Event
- Event 89534
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 172 units
- Official record key
device-enforcement:Z-0746-2022
Official wording
Reason: The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Code information: All units SKU number ACC-06-1000
Distribution pattern: US Nationwide
Derived failure modes
-
Unknown
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.