Recall Monitor
Health Products

VersaPulse Dual Wavelength and CO2 Laser Systems

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - General and plastic surgery
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
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
UltraPulse DUOService Manual PN SM-0000400GA-2000000
VersaPulse Pulse PowerSuite Holmium Surgical Laser SystemService Manual PN 0636-499-000638-800-01
AcuPulse DUOService Manual PN PB0000300GA-1000000
AcuPulse 40 WaveGuideService Manual PN PB0000301GA-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.

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