Z-0714-2024 Class II Ongoing
FDA device recall Z-0714-2024 was initiated by Ambu Inc. on December 5, 2023 and is designated Class II. Reason for recall: 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… The recall status is ongoing. Affected quantity: 11845 distributed US.
Recall Details
- Product Type
- Devices
- Report Date
- January 17, 2024
- Initiation Date
- December 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11845 distributed US
Product Description
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Reason for Recall
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.
Distribution Pattern
Domestic distribution nationwide.
Code Information
Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)