Z-1969-2025Class II

Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6)...

Name: Z-1969-2025 Azurion R1.x and R2.x systems; Model Numbers: (1) 722063, (2) 722064, (3) 722067, (4) 722068, (5) 722078, (6)...
Creator: Philips Medical Systems Nederland B.v.
Published: 2025-05-28
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2025-05-28 / Open, Classified / root cause: software

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of 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)... on 2025-05-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-1969-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-28
Posted: 2025-06-12
Recalling firm: Philips Medical Systems Nederland B.V.
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;
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: 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 tag: software
FDA root cause: Software design
Action: 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
Quantity in commerce: 9,707 units (2300 US, 7407 OUS)
Distribution: 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.
Product codes and lots: 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;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1969-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1969-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-18	2025-06-12

Product code OWB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)