Class 2 Device Recall Azurion R2.1

• Date Initiated by Firm: January 13, 2025
• Date Posted: February 04, 2025
• Recall Status: Open, Classified
• Recall Number: Z-1094-2025
• Recall Event ID: 96120
• 510(K)Number: K172822 K200917
• Product Classification: Interventional fluoroscopic x-ray system - Product Code OWB
• Product: Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223 (3) 722233
• Code Information: UDI: (1) 722224 00884838099258(21); (2) 722079 00884838085268(21); (3) 722234 00884838116771(21); (4) 722282 00884838110571(21)
• Recalling Firm/ Manufacturer: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.; Veenpluis 4-6; Best Netherlands
• Manufacturer Reason for Recall: Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) part of the Philips Allura and Azurion systems. During manual repositioning of the patient tabletop, a finger can get entrapped between the longitudinal guiding rails and the tabletop. This may result in an injury of the finger, applicable for operators and service personnel
• FDA Determined Cause: Device Design
• Action: Philips issued URGENT Medical Device Correction Letter via Certified Mail (USPS) on 1/13/25. Letter states reason for recall, health risk and action to take: " Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. " Follow the additional instructions when positioning the patient table included in Appendix B. These instructions include information of potential finger entrapment areas when moving the table. The information of this Appendix is being included in an Addendum to the Instructions for Use. Additionally, Philips is creating a Quick Reference Card. The Addendum and the Quick Reference Card will be available as from end of March 2025. Please refer to Appendix C on how to download the Addendum to the Instructions for Use and the Quick Reference Card. " In case that the affected system has been transferred to another organization, please send a copy of this Urgent Medical Device Correction letter to that organization and inform Philips about this transfer through the email account: IGT_Recalls@philips.com " Please complete and return the Response form attached to Philips promptly and no later than 30 days from receipt. Completing this form confirms receipt of the Urgent Medical Device Correction Letter and understanding of the issue and required actions to be taken. " Should you experience the issue reported in this letter, please report the event to Philips through your local Philips representative (1- 800-722-9377). Actions planned by Philips IGT-S to correct the problem Philips is releasing an addendum to the instructions for use and a Quick Reference Card that will be available for customers at the end of March 2025. Philips is working on the design of additional brackets for the AD7 tables, and a new redesigned table cover for AD7X tables (ref. FCOs: FCO72200516, FCO72200552, FCO72200553, FCO72200554, FCO72200555, FCO72200556). Philips will contact you to schedule a visit once the ne
• Quantity in Commerce: 1346 units US; 2582 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia and Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cuba, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Georgia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Guatemala, Guinea, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, JAMAICA, Japan, Jordan, Kazakhstan, Kenya, Korea, Republic of Kosovo, Kuwait, Kyrgyzstan, Lao People's Democratic Republic, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Malta, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Caledonia, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, State of Panama, Papua New Guinea, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Federation, Saudi Arabia, Senegal Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Trinidad and Tobago, Tunisia, Turkey, Turkmenistan, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam, Yemen.
• 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