FDA recall Z-0714-2024

Product

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.

Distribution

Domestic distribution nationwide.

Key facts

Status

Ongoing

Initiation date

2023-12-05

Report date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbia, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0714-2024