—#214108

Product

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; Software Version: All software versions;

FDA product code: OWB — Interventional Fluoroscopic X-Ray System
Device class: Class 2
Medical specialty: Radiology
510(k) numbers: K172822, K181830, K200917
Affected lot / code info: Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6) 722079, (7) 722221, (8) 722222, (9) 722223, (10) 722224, (11) 722225, (12) 722226, (13) 722227, (14) 722228, (15) 722280, (16) 722281, (17) 722282; UDI-DIs: (1) 00884838085275, (2) 00884838085282, (3) 00884838085350, (4) 00884838085367, (5) 00884838085251, (6) 00884838085268, (7) 00884838099203, (8) 00884838099210, (9) 00884838099241, (10) 00884838099258, (11) 00884838099265, (12) 00884838099272, (13) 00884838099227, (14) 00884838099234, (15) Not commercialized in the US, (16) Not commercialized in the US, (17) Not commercialized in the US;

Why it was recalled

A software issue was identified in the internal communication process between the system software and the X-ray generator firmware. Loss of imaging (X-ray) functionality caused by the software issue in either of the two situations identified could result in a delay of therapy. The potential delay may result in serious adverse health outcomes, including the possibility of death, especially when the system is used with patients undergoing complex and/or urgent interventions for potentially life-threatening conditions (e.g., acute ischemic stroke, ST-segment elevation myocardial ischemia, life-threatening bleedings).

Root cause (FDA determination)

Software design

Action the firm took

On May 28, 2025, URGENT MEDICAL DEVICE CORRECTION letters were sent to customers. Actions that should be taken by the customer / user in order to prevent risks for patients or users - Circulate this Urgent Medical Device Correction letter to all users of the system so that they are aware of the issue. - Avoid rapidly pressing and releasing the footswitch pedals. - In case X-ray functionality is not available following the situations described in this letter, perform a cold system restart of the system, as follows: o On the Review Module, press and hold Power Off . o Release the button when the indicator light begins to flash. o When the indicator light stops flashing, wait for 10 seconds. o On the Review Module, press and hold Power On . NOTE: Do not operate any of the controls while the system is powering on, as this may inhibit the start-up process - In case 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 your local Philips representative. - Keep this Urgent Medical Device Correction letter with the documentation of the system until Philips corrects your system. Ensure that the letter is in a place likely to be seen/viewed. - Complete and return the response form included in this Urgent Medical Device Correction 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. - If you experience the issue described in this letter, please report it to your local Philips representative. 5. Actions planned by Philips IGT Systems to correct the issue Philips will address the identified issue by implementing a software update in all affected systems. For systems featuring an Interventional Workspot and/or EchoNavigator, Philips will upgrade the Interventional Workspo

Recalling firm

Firm: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-Herz., Brazil, Brunei Darussal, Bulgaria, Cambodia, Cayman Islands, Chile, China, Colombia, Costa Rica, C¿te D'Ivoire, Croatia, Cyprus, Czech Republic, Denmark, Dominican Rep, Ecuador, Egypt, Estonia, Ethiopia, Fiji, Finland, France, French Polynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, IRAN, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kosovo, Kuwait, Kyrgyzstan, Lao, Latvia, Lebanon, Libya, Lithuania, Macao, Macedonia, Malaysia, Maldives, Martinique, Mauritania, Mauritius, Mexico, Moldova, Mongolia, Morocco, Myanmar, Nepal, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Oman, Pakistan, Palestine, Panama, Peru, Philippines, Poland, Portugal, Qatar, R¿union, Romania, Russian Fed., Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.

Timeline

Recall initiated: 2025-05-28
Posted by FDA: 2025-06-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214108. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.