China Daheng Group Inc. recalls Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Las

Recalled March 26, 2014 · FDA recall Z-1145-2014 · China Daheng Group

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 · FDA Class II

Units

238

Sold at

CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,

Description

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

Product

Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.

Manufacturer(s)

China Daheng Group Inc.

Made in

China

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →