FDA Medical Device Recalls (openFDA)
Ambu Inc.: Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
- Recall number
- Z-0714-2024
- Recalling firm
- Ambu Inc.
- Product
- Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
- Status
- Open, Classified
- Initiated
- 2023-12-05
- Posted
- 2024-01-11
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Device Design
- 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 (sap@ambu.com) or Tammy Feyerherm (tfey@ambu.com).
- Quantity
- 11845 distributed US
- Distribution
- Domestic distribution nationwide.
- Lot, serial or model codes
- Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
- 510(k) numbers
- ["K223299"]
- PMA numbers
- not on file
- Product code
- EOQ
- Firm FEI
- 1121788
- Firm city
- Columbia
- Firm state
- MD
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28