Summary
The FDA issued a Class II for Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2 by Ambu Inc.. 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 Advan.
Details
Source
Device Recall
External ID
Z-0714-2024
Action Date
2024-01-17
Status
Ongoing
Category
device
Product Description
Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Lot/Code Info: Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Quantity Affected: 11845 distributed US
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.
Distribution
Domestic distribution nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-05
Company
Columbia, MD
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 158 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Ambu Inc. has 6 FDA actions in our database, including 6 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Ambu Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Ambu Inc. have FDA actions?
Ambu Inc. has 6 FDA actions in our database, including 6 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0714-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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