Soltive Laser System
Brand(s)
Last updated
Summary
Product
Soltive Laser System
Issue
Medical devices - Device compatibility
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| Soltive Premium Superpulsed Laser System | All lots. | TFL-PLS |
| Soltive Wired Footswitch | All lots. | TFL-AFSW |
| Soltive Wireless Footswitch | All lots. | TFL-AFSWL |
Issue
Olympus investigated complaints received where customers reported difficulties in pairing the wireless footswitch with the Soltive laser, resulting in delays in surgical procedures or prolonged surgery. In an effort to mitigate any immediate and potential risk to patient health, Olympus is requiring Soltive laser users to have an Olympus wired footswitch (part number TFL-AFSW) available for immediate use as a backup in the event a wireless footswitch does not pair with the Soltive laser.
Recall start date: June 28, 2024
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General hospital and personal use
Companies
| Gyrus Acmi, Inc |
| 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-75813
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