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U.S. Department of Health and Human Services

Class 2 Device Recall Philips Azurion 7 M20

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  Class 2 Device Recall Philips Azurion 7 M20 see related information
Date Initiated by Firm August 13, 2021
Create Date September 14, 2021
Recall Status1 Open3, Classified
Recall Number Z-2476-2021
Recall Event ID 88546
510(K)Number K162148  
Product Classification Interventional fluoroscopic x-ray system - Product Code OWB
Product The Azurion series (within the limits of the used Operation Room table) are intended for use to perform:
"Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures.
"Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures.
Additionally:
"The Azurion series can be used in a hybrid Operation Room.
"The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.
Code Information Serial number: 921
Recalling Firm/
Manufacturer
Philips North America Llc
222 Jacobs St
Cambridge MA 02141-2289
Manufacturer Reason
for Recall
Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.
FDA Determined
Cause 2
Device Design
Action Philips notified accounts by Urgent Medical Device Recall letter via certified mailing United States Postal Service (USPS) on 8/13/21. Letter states reason for recall, health risk and action to take: Please place this Medical Device Recall letter with the documentation of the system until this correction has been implemented in your system. Additionally, please return the attached reply form to Phhilps to confirm that the users of the system have reviewed and understood this Medical Device Recall. Philips will correct the affected systems by replacing the ADUs. A Philips service representative will contact you to schedule the correct ion of your system. Please be assured that maintaining a high level of safety and quality is our highest priority. lf you need any further information or support concerning thls issue, please contact your local Philips representative: 1-800-722-9377 (reference FCO72200483
Quantity in Commerce 1 unit
Distribution US Nationwide distribution in the states of ID, MA, MI, TX, VA.
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 = OWB and Original Applicant = PHILIPS MEDICAL SYSTEMS NETHRLANDS BV
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