The Recall Desk
HighFDA (Devices)·Z-0714-2024·Announced 2024-01-17

Ambu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws

Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving risk of severe injury (fire, burns, smoke inhalation) from improper installation. No reported hospitalizations or actual incidents. Hazard is preventable through proper screw specification, meeting the criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

The Ambu aView 2 A Monitor (Catalog numbers 405011000 and 405011000US2) is being recalled by Ambu Inc. for fire and burn hazards related to improper mounting. Approximately 11,845 units have been distributed nationwide since May 2020.

Using mounting screws longer than 16mm when attaching the device to a VESA interface can penetrate the lithium-ion battery, causing fires, battery leakage, severe burns, smoke inhalation, and skin irritation. The device should only be mounted with M4 screws measuring 14-16mm in length.

Using shorter screws may result in unsecure device fastening. The Instructions for Use have been updated to warn users about proper mounting specifications. Healthcare facilities and other users should verify that their devices are installed with the correct screw size and length.

The recalled product

Product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Manufacturer
Ambu Inc.
Category
Medical Device — Anesthesia Monitoring
Hazard
  • fire
  • burn-injury
  • battery-hazard
  • smoke-inhalation

Distribution

Distributed nationwide across the United States.

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