Medical Device Recall: Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Ambu Inc. · December 5, 2023
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
Domestic distribution nationwide.
States Affected
NATIONWIDE
Quantity Affected
11845 distributed US
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0714-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.