Z-0440-2021 Class II Ongoing
FDA device recall Z-0440-2021 was initiated by Inova Lasers LLC on January 29, 2020 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 8 units.
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