Ambu aView 2 Advance recallZ-0714-2024 · Ambu Inc. · initiated Dec 5, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ambu Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Device Design
What the company is doing
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]).
Recall details
- Recall number
- Z-0714-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 5, 2023
- Posted by the FDA
- Jan 11, 2024
- Recalling firm
- Ambu Inc.
- Quantity
- 11845 distributed US
- Product code
- EOQ
- FDA submissions
- K223299
- Distribution
- Domestic distribution nationwide.
Product description
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Code information (models, lots, serial numbers)
Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Ambu aView™ 2 Advance 405011000Ambu A/S · ACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES)2 recalls4 reports
- Ambu aView™ 2 Advance 405011000US2Ambu A/S · Bronchoscope (flexible or rigid)1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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