China Daheng Group Inc.: Medical Device Recall in 2014 - (Recall #: Z-1145-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: July 15, 2013

Date Posted: March 26, 2014

Recall Number: Z-1145-2014

Event ID: 67520

Reason for Recall:

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

Status: Terminated

Product Quantity: 238

Code Information:

Denlase and Penlase Dental Laser Systems.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated