What's being recalled
Companies: Gyrus Acmi, Inc, 9600 Louisiana Ave. North, Brooklyn Park, Minnesota, United States, 55445.
How to identify it
Affected products: ViziShot 2 Flex; Lot or serial number: All unexpired lots.; Model or catalogue number: NA-U403SX-4019
The hazard
Olympus is removing all unexpired ViziShot 2 Flex (19g) devices due to a potential patient safety issue. Customers should not use any of the affected devices listed in the medical device recall letter and should return any affected products. Olympus is also reinforcing existing warnings in the Instructions for Use (IFU).
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)