HIGH

Philips Medical Systems Recalls Allura Xper FD20/10 Over Battery Issue

Philips Medical Systems Nederland B.V. recalled 87 Allura Xper FD20/10 medical imaging devices on September 3, 2025. The BIOS battery may deplete faster than expected, halting the system's start-up process without warning. Healthcare providers and patients should stop using these devices immediately.

Quick Facts at a Glance

Recall Date
September 3, 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

Hazard Information

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

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

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Product Details

The recalled product is the Allura Xper FD20/10, model number 722029. It was distributed worldwide, including the US and 66 other countries. The recall affects 87 units.

The Hazard

The BIOS battery may deplete quicker than anticipated, leading to a halt in the start-up process. There are no user messages indicating low battery power before the device fails to start.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. The potential risk remains high due to the device's critical function in medical imaging.

What to Do

Patients and healthcare providers must stop using the Allura Xper FD20/10 immediately. Follow the recall instructions from Philips Medical Systems and contact them or your healthcare provider for further guidance.

Contact Information

For more information, contact Philips Medical Systems Nederland B.V. or visit their website. Additional details are available at the FDA enforcement report link.

Key Facts

  • Recall date: September 3, 2025
  • Report date: October 8, 2025
  • Quantity recalled: 87 units
  • Affected countries: Worldwide distribution
  • Device classification: Class II

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Safety Assessment

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

Product Classification

Product TypeMedical Imaging Equipment
Sold At
Multiple Retailers

Product Details

Model Numbers
Model Numbers: 722029
UDI-DI: 00884838054219
Serial Numbers: 71
91
7
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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