Drug recall
WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.
FDA recall event 68870 · Class II · Biolase Technology Inc
Key facts
| Event ID | 68870 |
|---|---|
| Recall numbers | Z-2263-2014 |
| Recalling firm | Biolase Technology Inc |
| Product type | Devices |
| Products | WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface software (version 1.7). If an error occurs in the procedure screen, the air setting… |
| Initiation date | Jun 12, 2014 |
| Report date | Aug 27, 2014 |
| Termination date | Oct 6, 2014 |
| City | Irvine |
| State | CA |
| Country | United States |
| FEI number | 2027755 |
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: