Z-0440-2021 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 25, 2020
- Initiation Date
- January 29, 2020
- Termination Date
- N/A
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- 8 units
Product Description
Class IV New Era medical laser device
Reason for Recall
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
Distribution Pattern
US Nationwide Distribution
Code Information
New Era laser units