FDA-Device2024-01-17Class II
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Ambu Inc.
Hazard
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.
Sold states
Domestic distribution nationwide.
Affected count
11845 distributed US
Manufactured in
6721 Columbia Gateway Dr Ste 200, Columbia, MD, United States
Products
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0714-2024Don't want to check this manually?
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