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U.S. Department of Health and Human Services

Class 2 Device Recall Ambu aView 2 A Monitor

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  Class 2 Device Recall Ambu aView 2 A Monitor see related information
Date Initiated by Firm December 05, 2023
Date Posted January 11, 2024
Recall Status1 Open3, Classified
Recall Number Z-0714-2024
Recall Event ID 93599
510(K)Number K223299  
Product Classification Bronchoscope (flexible or rigid) - Product Code EOQ
Product Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
Code Information Catalog No. 405011000 - UDI-DI 5707480145089 Catalog No. 405011000US2 - UDI-DI 5707480156757 All products distributed since launch (May 2020)
Recalling Firm/
Manufacturer		 Ambu Inc.
6721 Columbia Gateway Dr Ste 200
Columbia MD 21046-3380
For Additional Information Contact Sanjay Parikh
800-262-8462
Manufacturer 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.
FDA Determined
Cause 2		 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 (sap@ambu.com) or Tammy Feyerherm (tfey@ambu.com).
Quantity in Commerce 11845 distributed US
Distribution Domestic distribution nationwide.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = EOQ and Original Applicant = Ambu A/S
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