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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