FDA Medical Device Recalls (openFDA)
China Daheng Group Inc.: Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
- Recall number
- Z-1145-2014
- Recalling firm
- China Daheng Group Inc.
- Product
- Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
- Status
- Terminated
- Initiated
- 2013-07-15
- Posted
- 2014-03-14
- Terminated
- 2015-04-17
- Reason
- 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
- Root cause
- Radiation Control for Health and Safety Act
- Action
- China Daheng Group, lnc.(CDH}, ensures tha they will execute seriously their plans for the repair of their electronics products Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System. China Daheng Group, lnc.(CDH}, will send their updated 238 pes of Diode Laser Therapy System operation manual and 200 pes of Dental soft Tissue Laser brochure to their Distributor. They will pay all of their expense including manufacture cost and freight cost. China Daheng Group, lnc.(CDH}, will remedy these defects through changing the manuals and brochures for their distributor, purchasers and any subsequent transferee. They will make new version manuals and brochures. Then they will send them to their customers and distributor after finishing inspection by their quality department according to the procedure Denlase-Y0029A for manual and brochure inspection. CDRH approves the CAP subject to the following condition: .Notification of all dealers and purchasers is to be made within 15 working days of receipt of this letter in the manner specified in 21 CFR 1003.21 and 1003.22. This office and the Food and Drug Administration (FDA) district office coordinator noted below are to be included in the notification.
- Quantity
- 238
- Distribution
- CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
- Lot, serial or model codes
- Denlase and Penlase Dental Laser Systems.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYB
- Firm FEI
- 3008705657
- Firm city
- Beijing
- Firm state
- Haidian District
- Firm country
- China
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28