PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.: Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X

Recall number

Z-1350-2026

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

Status

Open, Classified

Initiated

2026-01-26

Posted

2026-02-11

Terminated

not on file

Reason

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

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

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.

Lot, serial or model codes

System Model Numbers: (1)722227, (2)722231; UDI-DIs: (1)884838099227, (2)884838099258, (3)884838116740; Serial Numbers: All;

510(k) numbers

["K172822","K181830","K200917"]

PMA numbers

not on file

Product code

OWB

Firm FEI

3002807880

Firm city

Best

Firm state

not on file

Firm country

Netherlands

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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