Z-0714-2024Class II

Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2

Name: Z-0714-2024 Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Creator: Ambu Inc.
Published: 2023-12-05
License: https://open.fda.gov/license/

Ambu Inc. / initiated 2023-12-05 / Open, Classified / root cause: design

FDA source

Ambu Inc. began a recall of Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 on 2023-12-05. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0714-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-05
Posted: 2024-01-11
Recalling firm: Ambu Inc.
Product: Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Product code: EOQ Bronchoscope (Flexible Or Rigid)
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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]).
Quantity in commerce: 11845 distributed US
Distribution: Domestic distribution nationwide.
Product codes and lots: Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0714-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0714-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-17	2024-01-11

Product code EOQ

K223299Class IIAmbu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 AdvanceAmbu A/S / cleared 2023-06-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)