Reported Nov 25, 2020 · Ongoing
Class IV New Era medical laser device
Inova Lasers LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Inova Lasers LLC · 433 5th Ave Fl 6 · New York, NY · 10016-2207
Is this the product you have?
- Class IV New Era medical laser device
- Lot codes and dates
- New Era laser units
- Amount recalled
- 8 units
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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