Class 2 Device Recall Azurion

• Date Initiated by Firm: July 15, 2024
• Date Posted: August 08, 2024
• Recall Status: Open, Classified
• Recall Number: Z-2534-2024
• Recall Event ID: 94994
• 510(K)Number: K200917
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Philips Azurion Interventional Fluoroscopic X-ray System with Software Version Number: R1.0, R1.1, R1.2- Intended for Image guidance in diagnostic, interventional, and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular, and neuro procedure. Model Numbers: 722063, 722064, 722067, 722068, 722078 and 722079
• Code Information: Model /UDI-DI: (1) 722063 (01)00884838085275(21); (2) 722064 (01)00884838085282(21); (3) 722067 (01)00884838085350(21); (4) 722068 (01)00884838085367(21); (5) 722078 (01)00884838085251(21); (6) 722079 (01)00884838085268(21). Software Version Number: R1.0, R1.1, R1.2
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 4-6; Best Netherlands
• Manufacturer Reason for Recall: Potential Loss of Imaging (X-ray) Functionality and/or Longer Time to Perform Cold Restart
• FDA Determined Cause: Device Design
• Action: Philips issued URGENT Medical Device Correction Letter to US consignees on July 15th, 2024, via certified mail. Letter states reason for recall, health risk and action to take: Circulate this Urgent Medical Device Correction to all users of the system so that they are aware of the issue. " Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. " Should you experience a loss of imaging (X-ray) functionality or a prolonged system restart time, call your local Philips representative to report the event. " Complete and return the attached response form (page 4) to Philips promptly and no later than 30 days from receipt. This confirms that the users of the system have reviewed and understand this Urgent Medical Device Correction and required actions to be taken. Philips is working on a software release (R2.2.10) that will correct these two issues (ref. FCOs: FCO72200548, FCO72200580, FCO72200582, FCO72200583, FCO72200584, FCO72200592). For those systems that have an Interventional Workspot (IW) and/or EchoNavigator, Philips will upgrade the software version of the IW and/or EchoNavigator to maintain compatibility with the updated Philips Azurion system software (R2.2.10). Your local Philips representative will contact you to schedule a visit to install the software update once available. Philips expects this software to be released by Q1 2025. If you need additional information or support concerning these issues, contact your local Philips representative at 1-800- 722-9377 (Philips Customer Care Solutions Center).
• Quantity in Commerce: 3011 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Finland, France, Germany, Ghana, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan Palestine, State of Peru, Philippines, Poland, Portugal, R¿union Romania, Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Viet Nam.
• 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