FDA Enforcement
Class II
Ongoing
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Recall: Z-0714-2024
·
Reported January 17, 2024
Enforcement
- Recall Number
- Z-0714-2024
- Event ID
- 93599
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Ambu Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- January 17, 2024
- Initiation Date
- December 5, 2023
- Classification Date
- January 11, 2024
- Address
- 6721 Columbia Gateway Dr Ste 200, Columbia, MD, 21046-3380, United States
Description
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Reason
Instructions for Use have been updated to add the following warning: Use only M4 screws with the length of 14 16 mm when mounting Ambu aView 2 Advance on a VESA interface. Using longer screw lengths will penetrate the lithium-ion battery and result in a fire hazard and battery leakage which can cause severe burns, smoke inhalation and skin irritation. Using shorter screw lengths could result in unsecure device fastening.
Code Info
Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Distribution
Domestic distribution nationwide.
Quantity
11845 distributed US