Recall Z-2263-2014— Biolase Technology Inc

Name: FDA recall Z-2263-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-12

Class II · Terminated

Class II FDA medical device recall by Biolase Technology Inc, initiated 2014-06-12, terminated 2014-10-06. It names one FDA 510(k) clearance: K101658. Product: WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.. Reason: 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 will change to 1% and OFF..

Recalling firm: Biolase Technology Inc
Classification: Class II
Status: Terminated
Initiated: 2014-06-12
Terminated: 2014-10-06
Firm location: Irvine, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K101658 — WATERLASE MD TURBO PLUS MODEL 7200XXXBiolase Technology, Inc.·cleared 2010-08-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.

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 will change to 1% and OFF.

Data sourced from openFDA. This site is unofficial and independent of the FDA.