CanadaVersaPulse Dual Wavelength and CO2 Laser Systems by Lumenis Ltd. are affected — specifically UltraPulse DUO (Service Manual PN SM-0000400, model GA-2000000), VersaPulse Pulse PowerSuite Holmium Surgical Laser System (Service Manual PN 0636-499-00, model 0638-800-01), AcuPulse DUO (Service Manual PN PB0000300, model GA-1000000) and AcuPulse 40 WaveGuide (Service Manual PN PB0000301, model GA-0000140). The service manuals include incorrect or incomplete laser safety eyewear protection information, which could result in potential ocular harm. Contact the manufacturer if you require additional information.
What's being recalled
Companies: Lumenis Ltd., Yokneam Industrial Park, Yokneam, Israel, 2069204.
How to identify it
Affected products: UltraPulse DUO; Lot or serial number: Service Manual PN SM-0000400; Model or catalogue number: GA-2000000
Affected products: VersaPulse Pulse PowerSuite Holmium Surgical Laser System; Lot or serial number: Service Manual PN 0636-499-00; Model or catalogue number: 0638-800-01
Affected products: AcuPulse DUO; Lot or serial number: Service Manual PN PB0000300; Model or catalogue number: GA-1000000
Affected products: AcuPulse 40 WaveGuide; Lot or serial number: Service Manual PN PB0000301; Model or catalogue number: GA-0000140
The hazard
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 to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)