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Recall Observatory FDA recall evidence

Device 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.

Z-0340-2024

September 25, 2023

Class II

Product summary

Firm
Aizu Olympus Co., Ltd.
Event
Event 93222
Status
Ongoing
Classification
Class II
Quantity
33 units
Official record key
device-enforcement:Z-0340-2024

Official wording

Reason: 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

Code information: Model Numbers: MAF-DM2 (04953170407260), MAF-GM (04953170340369), MAF-GM2 (04953170407208), MAF-TM (04953170288630), MAF-TM2 (04953170407147).

Distribution pattern: Worldwide - US Nationwide distribution.

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    contamination that could lead