Lower risk Medical device recall · FDA · Published February 20, 2023

Philips SmartPerfusion Software Recalls: Inaccurate Medical Imaging Results

Philips recalls specific SmartPerfusion software versions due to potential inaccurate medical imaging results. Affected users should check their software version and contact Philips for updates.

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

🇺🇸 FDA recall #Z-1416-2023Medical device Philips ›

Lower-risk recall

There are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

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 versions of its SmartPerfusion software because technical issues can cause inaccurate medical imaging results. This could lead to incorrect diagnoses or treatment decisions if the software is used without the fix. Read more at govinfonow.com/recall/58868-philips-smartperfusion-software-recalls-inaccurate-medical-imaging-results.

Source Summary by GovInfoNow · govinfonow.com/recall/58868-philips-smartperfusion-software-recalls-inaccurate-medical-imaging-results · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1416-2023

Cite this page

“Philips SmartPerfusion Software Recalls: Inaccurate Medical Imaging Results.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58868-philips-smartperfusion-software-recalls-inaccurate-medical-imaging-results. Based on FDA recall #Z-1416-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1416-2023%22&limit=1).

The FDA announced on Feb. 20, 2023, that Philips Medical Systems Nederland B.V. is recalling SmartPerfusion software releases R1.0 through R1.1.6 due to technical issues in signal generation and processing that can lead to inaccurate presentations.

How to tell if you have it

SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
UDI: (01)00884838088566
SmartPerfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228
Software license key: 459801530271 sw key SmartPerfusion
UPC 00884838088566

The hazard

According to the FDA, there are technical issues related to signal generation and processing, which can lead to inaccurate presentations.

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 (Aug. 21, 2026), Philips IntraSight Plus Software Error May Cause Wrong Patient Diagnosis (Aug. 6, 2026) 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 SmartPerfusion software version is R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1, or R1.1.6. Also, look for model numbers 722003 through 722228 on the device.

Brand
Philips
Product
SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1416-2023	SmartPerfusion, release R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1 and R1.1.6; UDI: (01)00884838088566 SmartPerfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software license key: 459801530271 sw key SmartPerfusion	1461 units (236 US, 1225 OUS)
Z-1417-2023	2D Perfusion, release R1.0.x, R1.1.x, R1.2, and R1.2.1; UDI: (01)00884838059276 2D Perfusion with Allura Xper or Azurion model number: 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227 and 722228. Software License Keys: 459801071511 sw key 2D Perfusion (IW) 459800240601 sw key 2D Perfusion (XV)	549 units (75 US, 474 OUS)

Based on the official FDA remedy

What to do — step by step

Check Software Version
Review your SmartPerfusion software version to see if it matches the recalled versions (R1.0, R1.1, R1.1.1, R1.1.5, R1.1.5.1, R1.1.6).
Contact Philips
Reach out to Philips for guidance on updating the software or other remedies.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide - US Nationwide distribution.” 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 2 months after the firm started it.

Feb 20, 2023Firm started the recall
Apr 20, 2023FDA classified it Class II
Apr 26, 2023Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

What model numbers are affected?

The affected model numbers are 722003, 722006, 722008, 722010, 722012, 722013, 722020, 722023, 722026, 722027, 722028, 722029, 722035, 722038, 722039, 722058, 722059, 722064, 722067, 722068, 722078, 722079, 722223, 722224, 722225, 722226, 722227, and 722228.

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Link to this recall

<a href="https://govinfonow.com/recall/58868-philips-smartperfusion-software-recalls-inaccurate-medical-imaging-results">Philips SmartPerfusion Software Recalls: Inaccurate Medical Imaging Results (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-1416-2023 (February 20, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1416-2023 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.