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

FDA Recall #Z-0714-2024 — Class II — December 5, 2023

Recall #Z-0714-2024 Date: December 5, 2023 Classification: Class II Status: Ongoing

Product Description

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

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.

Recalling Firm

Ambu Inc. — Columbia, MD

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

11845 distributed US

Distribution

Domestic distribution nationwide.

Code Information

Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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