This page has been archived on the Web

Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.

Health product recall

WaterLase iPlus Dental Laser System (2014-06-03)

Starting date:
June 3, 2014
Posting date:
July 3, 2014
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-40277

Recalled Products

WaterLase iPlus Dental Laser System

Reason

During use of an iPlus unit with software version 1.7, if an error occurs when in any procedure screen, the air setting will change to 1% and off. After the error is cleared, the air setting will erroneously remain at 1% and off.

Affected products

WaterLase iPlus Dental Laser System

Lot or serial number

72120052

72140039

72140077

72140079

72140090

72140127

72140131

72140133

72140148

72140177

Model or catalog number

7200854

Companies
Manufacturer

Biolase, Inc.

4 Cromwell

Irvine

92618

California

UNITED STATES