CLASS II ONGOING Device recall · Reported 17 Jan 2024 · FDA Enforcement Report
aView 2 A Monitor recalled by Ambu
Ambu is recalling aView 2 A Monitor, distributed nationwide in the US. The recall was initiated on 5 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0714-2024
- FDA event ID
- 93599
- Recalling firm
- Ambu, Columbia, MD
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Dec 2023
- FDA classified
- 11 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Patient Monitors
Timeline
| 5 Dec 2023 | Recall initiated by company | |
| 11 Jan 2024 | Classified by FDA | +37 days |
| 17 Jan 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Where it was distributed
Domestic distribution nationwide.
Questions about this recall
Why was it 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.
Which lots are affected?
Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Where was it sold?
Domestic distribution nationwide.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ambu
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Spur II Labeled as the following recalled by Ambu | Ambu | Other | Nationwide |
| Device | CLASS II | aScope" 5 Broncho HD 5.6/2.8 Sampler Set recalled by Ambu | Ambu | Labeling Errors | Nationwide |
| Device | CLASS II | Ambu¿ VivaSight 2 DLT Endobronchial tube recalled | Ambu | Other | Nationwide |
| Device | CLASS II | aView 2 A Monitor-The Ambu aView 2 Advance is intended recalled | Ambu | Device Malfunction | Nationwide |
| Device | CLASS II | VivaSight 2 DLT recalled by Ambu | Ambu | Packaging Defects | Nationwide |
Other Patient Monitors recalls
All 1,022| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS III | Passport Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | T1 Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | cPM Series Patient Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | BeneVision Series Telemetry Monitor recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |
| Device | CLASS III | Panorama and Telemetry Monitoring System recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |