Ambu aView 2 A Monitor recall
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Why was Ambu aView 2 A Monitor 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
- Product
- Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
- Recalling firm
- Ambu Inc.
- Quantity
- 11845 distributed US
- Distribution
- Domestic distribution nationwide.
- Recall date
- January 17, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)