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Philips Medical Systems Recalls Allura Xper FD20 Biplane Over Electrical Hazard

Philips Medical Systems recalled 23 units of the Allura Xper FD20 Biplane on December 15, 2025. The recall affects systems with improperly installed drip trays, posing an electrical hazard. Health providers and patients must stop using the device immediately.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Health & Personal CareMedical DevicesModel Number: 722013System Product Name: Allura Xper FD20 BiplaneUDI-DI: 00884838059061

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
December 15, 2025
Status
ACTIVE
Severity
8/10

Quick Facts at a Glance

Recall Date
December 15, 2025
Hazard Level
HIGH
Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Product type
Biplane Imaging System
Model numbers
Model Number: 722013, System Product Name: Allura Xper FD20 Biplane, UDI-DI: 00884838059061, Serial Numbers: 601, 230, 370, 27, 320 +12 more
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    December 15, 2025

  2. Reported by FDA DEVICE

    January 21, 2026

  3. RecallRadar source check

    January 28, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

Hazard Information

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. or your healthcare provider for instructions. Notification method: Letter

About This Product

The Allura Xper FD20 Biplane is a medical imaging device used for various diagnostic purposes. Healthcare providers rely on this equipment to ensure accurate and safe imaging for patients.

Why This Is Dangerous

The lack of a properly installed drip tray can allow coolant to leak and contact electrical components. This poses a risk of electrical short-circuits, which can cause the system to shut down unexpectedly.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients and providers must stop using the device immediately, potentially disrupting medical services. This poses a safety risk that could lead to diagnostic delays.

Practical Guidance

How to identify if yours is affected

  1. Check the model number for 722013.
  2. Inspect the device for the presence of a drip tray beneath the cooling unit.
  3. Review any correspondence from Philips regarding the recall.

Where to find product info

The model number and serial numbers can typically be found on the device's label or documentation.

What timeline to expect

Expect a timeline of 4-6 weeks for refund processing once the device is returned.

If the manufacturer is unresponsive

  • Document all correspondence with Philips.
  • Reach out to the FDA for guidance on the recall.
  • Consider filing a complaint if the response is inadequate.

How to prevent similar issues

  • Research safety records of medical devices before purchase.
  • Ensure that devices have proper installation documentation.
  • Consult healthcare providers about recalls and safety updates.

Documentation advice

Keep records of your purchase, correspondence with Philips, and any images of the device for your safety records.

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Product Details

The recall involves the Allura Xper FD20 Biplane, Model Number 722013. The units were distributed worldwide, including the US and countries such as Argentina, Australia, and Brazil. The recall does not specify a price.

Key Facts

  • Class II recall
  • Potential electrical hazard
  • Immediate action required

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICAL

Product Classification

Product Details

Model Numbers
Model Number: 722013
System Product Name: Allura Xper FD20 Biplane
UDI-DI: 00884838059061
Serial Numbers: 601
230
+15 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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