Class IV New Era medical laser device
This recall is currently active, issued January 29, 2020. It was issued by Inova Lasers Llc.
- Company
- Inova Lasers Llc
- Recall Initiated
- January 29, 2020
- Recall Number
- Z-0440-2021
- Quantity
- 8 units
- Firm Location
- New York, NY
- Official Source
- View on FDA website ↗
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
US Nationwide Distribution
Lot / Code Info
New Era laser units
Root Cause
Radiation Control for Health and Safety Act
Action Taken
Notification by the manufacturer to affected persons, the firm will, without charge, remedy the defect or bring your product into compliance with each applicable Federal Standard in accordance with a plan to be approved by FDA.