Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0714-2024 — Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

U.S. FDA — Device Enforcement · United States · 2023-12-05 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0714-2024
Date of alert
2023-12-05
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Ambu Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
405011000
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.