Azurion 3 M15 System Model Numbers: (1) 722064, (2) 722222, (3) 722230, (4)722280(OUS only); Software Version Number - A

FDA device recall Z-1345-2026 · posted 2026-02-11 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

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.

Action taken

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.

Root cause

Device Design

Status

Open, Classified

Product code

OWB

Quantity affected

802 units (45 US, 757 OUS)

Distribution

Worldwide distribution - US Nationwide and the countries of Afghanistan, Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belarus, Belgium, Bolivia, Bosnia-He

Date initiated

2026-01-26

Date posted

2026-02-11

Location

Best, Netherlands

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