Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
- Company
- Ambu Inc.
- Recall Initiated
- December 5, 2023
- Posted
- January 11, 2024
- Recall Number
- Z-0714-2024
- Quantity
- 11845 distributed US
- Firm Location
- Columbia, MD
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.
Lot / Code Info
Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Root Cause
Device Design
Action Taken
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 (sap@ambu.com) or Tammy Feyerherm (tfey@ambu.com).