Reported Jan 17, 2024 · Ongoing

Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

Ambu Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Ambu Inc. · 6721 Columbia Gateway Dr Ste 200 · Columbia, MD · 21046-3380

Is this the product you have?

    • Ambu aView 2 A Monitor
    • Catalog numbers 405011000 and 405011000US2
Lot codes and dates
  • Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Amount recalled
11845 distributed US

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:54 PM UTC

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