Use caution Medical device recall · FDA · Published March 21, 2023

Philips Azurion System Software Recalls: X-ray Interruption Risk

Philips recalls Azurion system models with specific software versions due to potential X-ray interruption when disk space is full. Affected units may experience sudden procedure halts during medical imaging.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1647-2023Medical device Philips ›

Use caution until it’s fixed

Potential Loss of X-ray-When the full disk capacity is reached, X-Ray functionality will cease to be available there will be a sudden interruption of the procedure

Take action

Contact the company

Recalling firmPHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Veenpluis 4-6 · Best, Netherlands

✎ GovInfoNow plain-language explainer

Philips is recalling certain Azurion medical imaging systems with specific software versions. These systems may stop X-ray functionality suddenly if the internal storage fills up, which could interrupt critical medical procedures. Read more at govinfonow.com/recall/58689-philips-azurion-system-software-recalls-x-ray-interruption-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/58689-philips-azurion-system-software-recalls-x-ray-interruption-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1647-2023

Cite this page

“Philips Azurion System Software Recalls: X-ray Interruption Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58689-philips-azurion-system-software-recalls-x-ray-interruption-risk. Based on FDA recall #Z-1647-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1647-2023%22&limit=1).

The FDA announced on March 21, 2023, that Philips Medical Systems Nederland B.V. is voluntarily recalling Philips Azurion Systems with specific software versions due to a potential loss of X-ray functionality. The agency stated the hazard involves sudden procedure interruptions when disk capacity is reached.

How to tell if you have it

Philips Azurion System, software versions R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6
Azurion 3M12: Models 722063, 722221; UPCs 00884838085275, 00884838099203
Azurion 3M15: Models 722064, 722222; UPCs 00884838085282, 00884838099210
Azurion SM12: Model 722227; UPC 00884838099227
Azurion SM20: Model 722228; UPC 00884838099234
Azurion 7B12/12: Models 722067, 722225; UPCs 00884838085350, 00884838099265
Azurion 7820/15: Models 722068, 722226; UPCs 00884838085367, 00884838099272
Azurion 7M12: Models 722078, 722223; UPCs 00884838085251, 00884838099241
Azurion 7M20: Models 722079, 722224; UPCs 00884838085268, 00884838099258

The hazard

According to the FDA, when the full disk capacity is reached, X-ray functionality will cease to be available, causing a sudden interruption of the procedure.

Context

GovInfoNow's records show Philips Medical Systems Nederland B.V. has 58 other recalls on record since May 26, 2021. Other recent recalls of similar products include Philips Achieva 3.0T MRI Recalled: Software Issue May Terminate Scans (August 21, 2026), Philips Azurion R3.0 X-ray System Recall: Missing SSD Spacer Risk (October 27, 2025), and Philips PIC iX Essentials Software Freezes: Recall for Patient Data Issues (July 31, 2026).

How to tell if you have this one

Check if your Philips Azurion system has software versions R2.2.O, R2.2.1, R2.2.3, R2.2.5, or R2.2.6. Affected models include Azurion 3M12, 3M15, SM12, SM20, 7B12/12, 7820/15, and 7M12/20 with specific serial numbers listed in the recall notice.

Brand
Philips
Product
Philips Azurion System with software versions: R2.2.O, R2.2.1, R2.2.3, R2.2.5 and R2.2.6. Models/Model Number: (1)
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your system's software version by accessing the device settings or checking the label on the system.
Update Software
Contact Philips to obtain the latest software update to prevent X-ray interruptions.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Nationwide Foreign: Algeria Argentina Armenia Australia Austria Bahrain Bangladesh Belarus Belgium Bolivia Brazil Bulgaria Cambodia Chile China Colombia Costa Rica C¿te D'Ivoire Croatia Cyprus Czech Republic Denmark Dominican Rep Ecuador…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA published this recall 3 months after the firm started it.

Mar 21, 2023Firm started the recall
May 26, 2023FDA classified it Class II
Jun 7, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58689-philips-azurion-system-software-recalls-x-ray-interruption-risk">Philips Azurion System Software Recalls: X-ray Interruption Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1647-2023 (March 21, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1647-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.