FDA Device recall Z-0714-2024
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 by Ambu, citing 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 l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0714-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-12-05 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Ambu |
| Distribution | US |
Product
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
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.
Identifiers
| code_info | Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0714-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.