Drug recall
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical…
FDA recall event 67520 · Class II · China Daheng Group Inc.
Key facts
| Event ID | 67520 |
|---|---|
| Recall numbers | Z-1145-2014 |
| Recalling firm | China Daheng Group Inc. |
| Product type | Devices |
| Products | Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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 |
| Initiation date | Jul 15, 2013 |
| Report date | Mar 26, 2014 |
| Termination date | Apr 17, 2015 |
| City | Beijing |
| Country | China |
| FEI number | 3008705657 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: