Recall Z-0714-2024
Ambu Inc. · initiated December 5, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Codes / lots: Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
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.
FDA-determined 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).
Details
- Recall number
- Z-0714-2024
- Initiated
- December 5, 2023
- Posted by FDA
- January 11, 2024
- Product code
- EOQ – Bronchoscope (Flexible Or Rigid)
- Quantity
- 11845 distributed US
- Distribution
- Domestic distribution nationwide.
- Recalling firm
- Ambu Inc., Columbia, MD