PlainRecalls
FDA Devices Moderate Class II Ongoing

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.

Reported: March 16, 2022 Initiated: January 20, 2022 #Z-0746-2022

Product 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.

Reason for Recall

The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.

Details

Recalling Firm
Envisiontec US Llc
Units Affected
172 units
Distribution
US Nationwide
Location
Dearborn, MI

Frequently Asked Questions

What product was recalled?
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.. Recalled by Envisiontec US Llc. Units affected: 172 units.
Why was this product recalled?
The PCA 4000 may not fully cure EnvisionTEC dental resins to desired product specifications.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 16, 2022. Severity: Moderate. Recall number: Z-0746-2022.