Soltive Superpulsed Laser Fiber Single Use
Brand(s)
Last updated
Summary
Product
Soltive Superpulsed Laser Fiber Single Use
Issue
Medical devices - Labelling and packaging
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 Superpulsed Laser Fiber Single Use |
All lots. |
TFL-FBX550S |
Soltive Superpulsed Laser Ball Tip Fiber Single Use |
All lots. |
TFL-FBX150BS |
Issue
There are errors identified in the Soltive Single-use Laser Fiber instructions for use. Olympus conducted an internal review of the Soltive Single-use Fibers and identified inconsistencies in the IFU.
Recall start date: December 1, 2023
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-74736
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