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Inova Lasers LLC recalls Class IV New Era medical laser device
Recalled November 25, 2020 · FDA recall Z-0440-2021 · Inova Lasers
Hazard
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 Class II
Units
8 units
Sold at
US Nationwide Distribution
Description
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.
Product
Class IV New Era medical laser device
Manufacturer(s)
Inova Lasers LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →