Z-1145-2014 Class II Terminated
FDA device recall Z-1145-2014 was initiated by China Daheng Group Inc. on July 15, 2013 and is designated Class II. 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 The recall status is terminated (terminated April 17, 2015). Affected quantity: 238.
Recall Details
- Product Type
- Devices
- Report Date
- March 26, 2014
- Initiation Date
- July 15, 2013
- Termination Date
- April 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 238
Product Description
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
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
Distribution Pattern
CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
Code Information
Denlase and Penlase Dental Laser Systems.