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Ambu Inc. recalls Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Recalled January 17, 2024 · FDA recall Z-0714-2024 · Ambu
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. · FDA Class II
Units
11845 distributed US
Sold at
Domestic distribution nationwide.
Description
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.
Product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Manufacturer(s)
Ambu Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →