FDA Device recall Z-1145-2014
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered
- FDA Device
- Class II
- terminated
- Published 2014-03-26
On 2014-03-26 the FDA classified a Class II recall of Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered by China Daheng Group, citing 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 Pe….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1145-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-07-15 |
| Published | 2014-03-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | China Daheng Group |
| Distribution | CA, FL, IL, KS, KY, NJ, NY, PA, WI, WY |
Product
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
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
Identifiers
| code_info | Denlase and Penlase Dental Laser Systems. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1145-2014%22
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