Inova Lasers recalls Class IV New Era medical laser devices due to failure to meet electronic radiation control standards. Affected units may pose radiation risks if used improperly.
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.
Inova Lasers is recalling Class IV New Era medical laser devices because they didn't follow proper radiation control standards. This could lead to radiation exposure risks if the devices are used incorrectly.
The devices failed to meet radiation control standards, which could result in improper radiation emission. This might cause unintended radiation exposure during medical procedures if not properly managed.
Medical professionals using the New Era laser devices are likely affected. Those with the devices in their practice or at home may be at risk.
The recalled items are Class IV New Era medical laser devices. They were sold by Inova Lasers LLC but specific model numbers or dates aren't mentioned in the recall notice.
Review the device label for the product name and model number to confirm if it matches the recalled Class IV New Era medical laser devices.
The recall is due to Inova Lasers failing to comply with electronic radiation control standards for medical laser devices.
The recall notice does not specify a remedy or action steps for affected users.
The recall notice does not mention specific model numbers or dates of sale.
We’ve drafted a message you can send Inova Lasers to request your refund or repair — edit it as you like.
Subject: Recall Z-0440-2021 — Inova Lasers Inova Lasers Hello, I own a Inova Lasers that is covered by recall Z-0440-2021 from Inova Lasers. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
