Soltive Laser System
Brand(s)
Summary
Contact the manufacturer if you require additional information.
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
| Gyrus Acmi, Inc |
| 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445 |
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