Health product recall

VersaPulse Dual Wavelength and CO2 Laser Systems

Brand(s)
Last updated

Summary

Product
VersaPulse Dual Wavelength and CO2 Laser Systems
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information.

Audience
Industry

Affected products

Affected products

Lot or serial number

Model or catalogue number

UltraPulse DUO

Service Manual PN SM-0000400

GA-2000000

VersaPulse Pulse PowerSuite Holmium Surgical Laser System

Service Manual PN 0636-499-00

0638-800-01

AcuPulse DUO

Service Manual PN PB0000300

GA-1000000

AcuPulse 40 WaveGuide

Service Manual PN PB0000301

GA-0000140

Issue

Boston Scientific has identified that service manuals for the VersaPulse (VPPs) Dual Wavelength (DW) and CO2 laser systems include incorrect or incomplete laser safety eyewear protection information, resulting in the potential for ocular harm.

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Companies
Lumenis Ltd.
Yokneam Industrial Park, Yokneam, Israel, 2069204
Published by
Health Canada
Audience
Industry
Recall class
Type II
Recall date
Identification number
RA-82062

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