Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Recall
- Recall Number
- Z-0714-2024
- Event Number
- 93599
- Firm
- Ambu Inc.
- FEI Number
- 1121788
- Product Code
- EOQ
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- December 5, 2023
- Posted
- January 11, 2024
- Address
- 6721 Columbia Gateway Dr, Ste 200, Columbia, MD, 21046-3380
Description
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
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.
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]).
Domestic distribution nationwide.
11845 distributed US