Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 72

FDA device recall Z-2931-2026 · posted 2026-08-10 · Open, Classified

Recall details

Recalling firm

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Reason for recall

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

Action taken

Philips issued an URGENT Medical Device Correction to its consignees on 7/16/2026 via certified mailing. The notice explained the issues, potential harms associated with the issues, and provide instructions for the safe operations of the device pending a software update. The instructions are as follows: Issue 1: Image quality degradation If image quality degradation is observed, perform a cold restart of the system as soon as clinically feasible, following the steps described in the Instructions for Use: 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: A cold restart of the system takes up to 6 minutes from initiation of the cold restart until all system functionality is available. " Issue 2: Loss of geometry movements If loss of geometry movements is observed, restart the geometry following the steps described in the Instructions for Use: o On the Control Module, press the Emergency Stop button. o On the Review Module, press the Power On button for approximately 2 seconds. NOTE: A geometry restart may take up to 2 minutes to complete. " Ensure this notice is distributed to all relevant users of the system. " Post this notice near affected devices for ease of reference, where applicable. " If the affected device has been transferred to another organization, please forward this notice to that organization and inform Philips through your local representative. " Keep this Urgent Medical Device Correction with the documentation of the system until Philips corrects your system. " If you experience an issue described in this letter, please report it to your local Philips representative. " 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 t

Root cause

Software design

Status

Open, Classified

Product code

OWB

Quantity affected

10872 units

Distribution

Worldwide

Date initiated

2026-07-16

Date posted

2026-08-10

Location

Best, Netherlands

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