Device product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Z-0714-2024
Product summary
- Firm
- Ambu Inc.
- Event
- Event 93599
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 11845 distributed US
- Official record key
device-enforcement:Z-0714-2024
Official wording
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 information: Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Distribution pattern: Domestic distribution nationwide.
Derived failure modes
-
Unknown
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.