FDAFDA · Food and drugs·Recall number Z-0050-2014
Solea 1.0 Laser Surgical instrument for use in general and plastic surgery and dermatology.
Published October 30, 2013 · Recall initiated: September 12, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Specific error condition could lead to unintended laser emission during laser activation.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Convergent Dental
- Distributor
- US distribution including states of: MA, CT, NY.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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