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-13CDS1-7QRE-1B-JU-13CDS1-22TZ-1B-JU-13CDS1-PNJZ-1B-AU-13CDS1-A4CQ-1B-AU-13
- Serial Numbers
- 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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