Z-1350-2026Class II

Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X...

Name: Z-1350-2026 Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X...
Creator: Philips Medical Systems Nederland B.v.
Published: 2026-01-26
License: https://open.fda.gov/license/

Philips Medical Systems Nederland B.V. / initiated 2026-01-26 / Open, Classified / root cause: design

FDA source

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. began a recall of Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X on 2026-01-26. FDA classified it as Class II and gives the reason as "Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1350-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-26
Posted: 2026-02-11
Recalling firm: Philips Medical Systems Nederland B.V.
Product: Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
Product code: OWB Interventional Fluoroscopic X-Ray System
Reason for recall: Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.
Root cause tag: design
FDA root cause: Device Design
Action: On January 26, 2026 URGENT Medical Device Correction letters were sent to customers. Actions to be taken: " Circulate this URGENT Medical Device Correction letter to all users of the system so that they are aware of the issue. " Read and follow the additional instructions in Appendix A regarding the use and configuration of the Reset Geometry function. " Keep Appendix A together with the documentation of the system. Ensure that the letter is in a place likely to be seen/viewed. " Confirm the Reset Geometry function that best suits your clinical workflow. If required, you may request Philips to change the settings. When using a third-party stand-alone device or a stationary accessory. You can request a configuration change free of charge within six (6) months from the date of this Urgent Medical Device Correction letter by contacting your local Philips representative. " 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.
Quantity in commerce: 326 units (10 US, 316 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., Botswana, 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, El Salvador, Estonia, Ethiopia, Fiji, Finland, France, FrenchPolynesia, Germany, Ghana, Gibraltar, Greece, Guadeloupe, Honduras, 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, Malta, 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., Russian Federation, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Syrian Arab Republic, Taiwan, Tanzania, Thailand, Tunisia, T¿rkiye, Turkmenistan, Ukraine, United Kingdom, Uruguay, Utd.Arab.Emir., Uzbekistan, Vietnam, Yemen.
Product codes and lots: System Model Numbers: (1)722227, (2)722231; UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740; Serial Numbers: All;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1350-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1344-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11
Z-1345-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11
Z-1346-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11
Z-1347-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11
Z-1348-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11
Z-1349-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11
Z-1350-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11
Z-1351-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-02-18	2026-02-11

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)