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RecallWatchMedical Device Safety
Class IIOngoingZ-2931-2026

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion Rystem

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Best, NetherlandsReported Aug 19, 2026 · 7 days ago
Legal News Analyst ·

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

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 722227, 722228, 722280*, 722281*, and 722282* (*These models are distributed only in China), with Software Version Number R2.2.10 and R2.1.10* (*This software version is distributed only in China); Interventional Fluoroscopic X-Ray System

Lot / code information

UDI
(01)00884838099258(21)1229, (01)00884838099258(21)450, (01)00884838085251(21)302, (01)00884838099258(21)1576, (01)00884838099258(21)1577, (01)00884838099258(21)1578 — +1186 moreShow all
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(01)00884838085268(21)673, (01)00884838099234(21)67, (01)00884838085268(21)298, (01)00884838085268 …
Additional code information

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What the firm is doing

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

DistributionShow details

Worldwide

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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