Public recall detail

VersaPulse Dual Wavelength and CO2 Laser Systems

2026-05-13

medium
General and plastic surgery Labelling and packaging
Quick summary

Quick summary: VersaPulse Dual Wavelength and CO2 Laser Systems. Reason: Labelling and packaging. Category: General and plastic surgery. Date: 2026-05-13.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: VersaPulse Dual Wavelength and CO2 Laser Systems. Reason: Labelling and packaging. Category: General and plastic surgery. Date: 2026-05-13.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandLumenis Ltd.
ProductVersaPulse Dual Wavelength and CO2 Laser Systems
IssueMedical devices - Labelling and packaging
Recall classType II
IdentificationRA-82062

Affected products

ProductUltraPulse DUO
LotService Manual PN SM-0000400
ModelGA-2000000
Serial numberService Manual PN SM-0000400
DescriptionUltraPulse DUO
ProductVersaPulse Pulse PowerSuite Holmium Surgical Laser System
LotService Manual PN 0636-499-00
Model0638-800-01
Serial numberService Manual PN 0636-499-00
DescriptionVersaPulse Pulse PowerSuite Holmium Surgical Laser System
ProductAcuPulse DUO
LotService Manual PN PB0000300
ModelGA-1000000
Serial numberService Manual PN PB0000300
DescriptionAcuPulse DUO
ProductAcuPulse 40 WaveGuide
LotService Manual PN PB0000301
ModelGA-0000140
Serial numberService Manual PN PB0000301
DescriptionAcuPulse 40 WaveGuide

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.

What you should do

  • Contact the manufacturer if you require additional information.
Additional official information
AudienceIndustry
CategoryHealth products - Medical devices - General and plastic surgery
CompaniesLumenis Ltd. Yokneam Industrial Park, Yokneam, Israel, 2069204
Recall date2026-03-30
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-82062
Background{}
CompaniesLumenis Ltd. Yokneam Industrial Park, Yokneam, Israel, 2069204
AudiencesIndustry
Source updated2026-05-13

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

Official source Monitor products Back to recalls

Starting...

Related recalls

Similar recalls and safety notices.

Loading related recalls...