Reported Oct 30, 2013 · Terminated

Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.

Convergent Dental

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: Convergent Dental · 2 Vision Dr · Natick, MA · 01760-2086

Is this the product you have?

  • Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Lot codes and dates
  • Serial Numbers
    • CDS1-DVSU-1B-JU-13
    • CDS1-7QRE-1B-JU-13
    • CDS1-22TZ-1B-JU-13
    • CDS1-PNJZ-1B-AU-13
    • CDS1-A4CQ-1B-AU-13
Amount recalled
5

Where it was sold

Why it was recalled

Specific error condition could lead to unintended laser emission during laser activation.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 15, 2013 · Data as of Sep 19, 5:24 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.