Use caution Medical device recall · FDA · Published August 13, 2021

Philips Allura Xper Series Recall: Risk of Overheating from 480V Mains

Philips recalls Allura Xper series medical imaging devices due to potential overheating from 480V hospital power, causing reduced X-ray performance and possible burning smell. Affected units have specific serial numbers.

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

🇺🇸 FDA recall #Z-2474-2021Medical device Philips ›

Use caution until it’s fixed

Early life failure of the ADUs only occurs when the hospital mains provide 480V to the system. This current voltage may lead to saturation and overheating of the coils that protect the IGBTs (insulated-gate bipolar transistor) of the ADU. The overheating may generate a peculiar burning smell that may be noticed. In some instances, this burning smell may be noticed before the ADU fails. When the ADU fails the X-ray performance of the system is reduced to Emergency Fluoroscopy. Exposure will not be possible and image quality will be reduced.

Take action

Contact the company

Recalling firmPhilips North America Llc222 Jacobs St · Cambridge, MA 02141-2289

✎ GovInfoNow plain-language explainer

Philips is recalling its Allura Xper series medical imaging devices because they can overheat when connected to 48:00V hospital power, leading to reduced X-ray performance and possible burning smells. This could affect patient imaging safety if the device fails during procedures. Read more at govinfonow.com/recall/61947-philips-allura-xper-series-recall-risk-of-overheating-from-480v.

Source Summary by GovInfoNow · govinfonow.com/recall/61947-philips-allura-xper-series-recall-risk-of-overheating-from-480v · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2474-2021

Cite this page

“Philips Allura Xper Series Recall: Risk of Overheating from 480V Mains.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61947-philips-allura-xper-series-recall-risk-of-overheating-from-480v. Based on FDA recall #Z-2474-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2474-2021%22&limit=1).

Philips North America LLC recalled The Allura Xper series imaging systems on Aug. 13, 2021, due to early life failure risks when connected to 480V hospital mains, according to the FDA. The hazard may cause overheating and reduced X-ray performance.

How to tell if you have it

Brand: Philips
Product: The Allura Xper series
Serial numbers: 48, 66, 67, 160

The hazard

The FDA said early life failure of the ADUs occurs when hospital mains provide 480V to the system, potentially leading to saturation and overheating of coils protecting the IGBTs. This overheating may generate a peculiar burning smell noticed before the ADU fails. When the ADU fails, X-ray performance is reduced to Emergency Fluoroscopy with no exposure possible and reduced image quality.

Context

GovInfoNow's records show Philips North America LLC has 129 other recalls on record since July 12, 2017. Recent recalls include the Evolution upgrade 1.5T and Evolution upgrade 3.0T (Aug. 21, 2026), the Spectral CT 7500 Scanner (Aug. 18, 2026), and Philips Ingenuity CT Scanners (Aug. 7, 2026). Other recent recalls of similar products include the Philips Allura Xper FD10C Medical System Recall (Dec. 15, 2025), the Philips Allura Xper FD10F Medical System Recall (Dec. 15, 2025), and the Philips Allura Xper FD20/10 recall (Dec. 15, 2025).

How to tell if you have this one

The Allura Xper series is used for vascular, cardiovascular, and neurovascular imaging. Affected units have serial numbers starting with 48, 66, 67, or 160.

Brand
Philips
Category
Medical device

FDA recall event · 3 products

All 3 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
Terminated
Distribution
US Nationwide distribution in the states of ID, MA, MI, TX, VA.

Recall number	Product, codes & lots	Quantity
Z-2474-2021	The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis. "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). "Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."; Serial numbers: 48, 66, 67, 160	4 units
Z-2475-2021	The Allura Xper series is intended for use on human patients to perform: "Vascular, cardiovascular and neurovascular imaging applications, including diagnostic, interventional and minimally invasive procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTAs, stent placements, embolisations and thrombolysis." "Cardiac imaging applications including diagnostics, interventional and minimally invasive procedures (such as PTCA, stent placing, atherectomies), pacemaker implanatations, and electrophysiology (EP). Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures."; Serial number: 7	1 unit
Z-2476-2021	The Azurion series (within the limits of the used Operation Room table) are intended for use to perform: "Image guidance in diagnostic, interventional and minimally invasive surgery procedures for the following clinical application areas: vascular, non-vascular, cardiovascular and neuro procedures. "Cardiac imaging applications including diagnostics, interventional and minimally invasive surgery procedures. Additionally: "The Azurion series can be used in a hybrid Operation Room. "The Azurion series contain a number of features to support a flexible and patient centric procedural workflow.; Serial number: 921	1 unit

Based on the official FDA remedy

What to do — step by step

Check Device Serial Number
Look for serial numbers starting with 48, 66, 67, or 160 on the device or documentation.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 5 states.

FDA distribution: “US Nationwide distribution in the states of ID, MA, MI, TX, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Idaho, Massachusetts, Michigan, Texas, Virginia.

Recall timeline

FDA terminated this recall 2.6 years after the firm started it.

Aug 13, 2021Firm started the recall
Sep 14, 2021FDA classified it Class II
Sep 22, 2021Published in FDA’s Enforcement Report
Mar 11, 2024FDA terminated the recall

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/61947-philips-allura-xper-series-recall-risk-of-overheating-from-480v">Philips Allura Xper Series Recall: Risk of Overheating from 480V Mains (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-2474-2021 (August 13, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2474-2021 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.