FDA Enforcement
Class II
Ongoing
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.
Recall: Z-0340-2024
·
Reported November 29, 2023
Enforcement
- Recall Number
- Z-0340-2024
- Event ID
- 93222
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Aizu Olympus Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 29, 2023
- Initiation Date
- September 25, 2023
- Classification Date
- November 17, 2023
- Address
- 3 Chome 1-1, Niiderakita, Aizuwakamatsu, N/A, N/A, Japan
Description
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.
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 Info
Model Numbers: MAF-DM2 (04953170407260), MAF-GM (04953170340369), MAF-GM2 (04953170407208), MAF-TM (04953170288630), MAF-TM2 (04953170407147).
Distribution
Worldwide - US Nationwide distribution.
Quantity
33 units