Z-0440-2021 Class II Ongoing
FDA device recall Z-0440-2021 was initiated by Inova Lasers LLC on Jan 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
- Nov 25, 2020
- Initiation Date
- Jan 29, 2020
- 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0440-2021
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026