Reported Aug 27, 2014 · Terminated

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

Biolase Technology Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Biolase Technology Inc · 4 Cromwell · Irvine, CA · 92618-1816

Is this the product you have?

    • WaterLase iPlus Dental Laser System
    • Part No. 7200854-XX Software Upgrade Kit
    • Part No. 6201463
Lot codes and dates
  • Serial No.

    116 of 116 codes

    • 72110047
    • 72111060
    • 72110077
    • 72110128
    • 72110263
    • 72110281
    • 72110286
    • 72110343
    • 72110469
    • 72110836
    • 72110940
    • 72110983
    • 72130260
    • 72130263
    • 72140014
    • 72140033
    • 72140034
    • 72140036
    • 72140037
    • 72140038
    • 72140041
    • 72140042
    • 72140045
    • 72140046
    • 72140047
    • 72140048
    • 72140052
    • 72140054
    • 72140057
    • 72140058
    • 72140059
    • 72140060
    • 72140061
    • 72140063
    • 72140064
    • 72140066
    • 72140068
    • 72140070
    • 72140072
    • 72140078
    • 72140110
    • 72140111
    • 72140083
    • 72140114
    • 72140165
    • 72140176
    • 72140126
    • 72140129
    • 72140129
    • 72140130
    • 72140136
    • 72140139
    • 72140140
    • 72140141
    • 72140144
    • 72140145
    • 72140152
    • 72140153
    • 72120052
    • 72140039
Amount recalled
117 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Oct 6, 2014 · Data as of Sep 19, 4:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.