Class II — Ambu Inc.
| Recalling firm | Ambu A/S |
|---|---|
| Registered facility | AMBU INNOVATION GMBH (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 |
| Quantity | 11845 distributed US |
| Distribution | Domestic distribution nationwide. |
| Initiated | 2023-12-05 |
| Classified | 2024-01-11 |
| Recall number | Z-0714-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Ambu Inc. (Z-0714-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93599/
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