Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
FDA Recall Z-0714-2024 · Posted 2024-01-11
Recalling FirmAmbu Inc.
Recall StatusOpen, Classified
Product CodeEOQ
Date Initiated2023-12-05
Product Quantity11845 distributed US
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.
Firm Action
On December 5, 2023, the firm began notifying their customers via Urgent Field Safety Notice (Correction) letters. Customers were provided with an insert of Instructions for Use to include with their Instructions for Use booklet that highlights the new warning.
Should you have additional questions, please contact Sanjay Parikh ([email protected]) or Tammy Feyerherm ([email protected]).
Root Cause
Device Design
Distribution Pattern
Domestic distribution nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.