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Aizu Olympus Co., Ltd. recalls Mobile airway scope-diagnosis and observation to access airway anatomy, endotracheal/endobronchial intubation and manage
Recalled November 29, 2023 · FDA recall Z-0340-2024 · Aizu Olympus
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 · FDA Class II
Units
33 units
Sold at
Worldwide - US Nationwide distribution.
Description
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
Product
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.
Manufacturer(s)
Aizu Olympus Co., Ltd.
Made in
Japan
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →