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 TFL-FBX150S TFL-FBX200S TFL-FBX365S TFL-FBX940S |
| Soltive Superpulsed Laser Ball Tip Fiber Single Use | All lots. | TFL-FBX150BS TFL-FBX200BS |
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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