FDA-Device2023-11-29Class II
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Aizu Olympus Co., Ltd.
Hazard
Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection
Sold states
Worldwide - US Nationwide distribution.
Affected count
33 units
Manufactured in
3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, Japan
Products
Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Numbers: MAF-DM2, MAF-GM, MAF-GM2, MAF-TM, MAF-TM2.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0340-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief