Official recall record
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2023-12-05
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Ambu Inc.
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Verify at the source:
US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.
Record last checked against the registry on 2026-05-31.
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