Recall Z-0440-2021
Inova Lasers LLC · initiated January 29, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Class IV New Era medical laser device
Codes / lots: New Era laser units
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.
FDA-determined 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.
Details
- Recall number
- Z-0440-2021
- Initiated
- January 29, 2020
- Product code
- GEX – Powered Laser Surgical Instrument
- Quantity
- 8 units
- Distribution
- US Nationwide Distribution
- Recalling firm
- Inova Lasers LLC, New York, NY