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Philips Medical Imaging System Recalled Over Electrical Hazard

Philips recalled 14 units of the Allura Xper FD10/10 due to a potential electrical hazard. The recall affects medical imaging systems distributed worldwide. If the drip tray beneath the cooling unit is not installed, coolant may contact electrical components, leading to system shutdown.

Official notice
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.Health & Personal CareMedical DevicesModel Number: 722005System Product Name: Allura Xper FD10/10UDI-DI: N/A

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
Medical Imaging System
Model numbers
Model Number: 722005, System Product Name: Allura Xper FD10/10, UDI-DI: N/A, Serial Numbers: 93, 269, 530, 306, 307 +9 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 FD10/10 is a medical imaging system used in healthcare settings for diagnostic purposes. Healthcare providers rely on these systems for accurate imaging to assist in patient diagnosis and treatment.

Why This Is Dangerous

The hazard arises when the drip tray beneath the cooling unit is not installed correctly. This oversight can lead to coolant leaking and potentially contacting electrical components, resulting in dangerous short-circuits.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall affects a limited number of devices, but the potential for electrical failure could compromise patient safety and lead to system outages in medical facilities.

Practical Guidance

How to identify if yours is affected

  1. Verify the model number as Allura Xper FD10/10, Model Number: 722005.
  2. Check the serial numbers against the list provided by Philips for affected units.
  3. Look for any documentation regarding previous field corrections related to the device.

Where to find product info

Serial numbers and model information can typically be found on the device's label or user manual.

What timeline to expect

Expect a processing timeline of 4-6 weeks for refunds or replacements after contacting Philips.

If the manufacturer is unresponsive

  • Document your communication attempts with Philips.
  • Reach out to your healthcare provider for assistance in the recall process.
  • Report the issue to the FDA if you do not receive a response.

How to prevent similar issues

  • Always check for recall information before purchasing medical devices.
  • Ensure that devices are properly maintained and inspected for safety compliance.
  • Consult with healthcare providers about the safety records of medical devices.

Documentation advice

Keep copies of all correspondence with Philips, including emails and letters, along with any receipts related to the purchase of the device.

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Product Details

The recalled product is the Allura Xper FD10/10, Model Number: 722005. It was distributed worldwide, including the US and various countries. The quantity recalled is 14 units.

Key Facts

  • Recalled product: Allura Xper FD10/10
  • Hazard: Electrical short-circuit risk
  • Recall date: December 15, 2025

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: 722005
System Product Name: Allura Xper FD10/10
UDI-DI: N/A
Serial Numbers: 93
269
+12 more
Affected States
ALL
Report Date
January 21, 2026
Recall Status
ACTIVE

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