Class IV New Era medical laser device
Reported: November 25, 2020 Initiated: January 29, 2020 #Z-0440-2021
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.
Details
- Recalling Firm
- Inova Lasers LLC
- Units Affected
- 8 units
- Distribution
- US Nationwide Distribution
- Location
- New York, NY
Frequently Asked Questions
What product was recalled? ▼
Class IV New Era medical laser device. Recalled by Inova Lasers LLC. Units affected: 8 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 25, 2020. Severity: Moderate. Recall number: Z-0440-2021.
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