FDAFDA · Food and drugs·Recall number Z-1145-2014
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
Published March 26, 2014 · Recall initiated: July 15, 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
Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- China Daheng Group Inc.
- Distributor
- CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
- Lot
- Denlase and Penlase Dental Laser Systems.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- China
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