HIGH

Philips Medical Systems Recalls Allura Xper FD10C Over Battery Risk

Philips Medical Systems Nederland B.V. recalled the Allura Xper FD10C model on September 3, 2025, due to a potential BIOS battery issue. The battery may deplete faster than expected, halting system startup without warning. Only two units are affected in the U.S.

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

Product Details

The recalled product is the Allura Xper FD10C, Model Number 722001. It was sold worldwide, including the U.S. and numerous other countries. The recall affects only two units.

The Hazard

The BIOS battery may deplete more rapidly than anticipated. If this occurs, the system will not start and there will be no warning messages.

Reported Incidents

There are no reported incidents or injuries related to this recall at this time. Allura Xper FD10C users are urged to act immediately.

What to Do

Stop using the Allura Xper FD10C immediately. Follow the instructions provided by the manufacturer and contact Philips Medical Systems or your healthcare provider for further guidance.

Contact Information

For more information, contact Philips Medical Systems Nederland B.V. Visit the FDA recall page for updates.

Key Facts

  • Recall date: September 3, 2025
  • Report date: October 8, 2025
  • Quantity recalled: 2 units in the U.S.
  • Affected countries: Worldwide distribution

Safety Assessment

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

Product Classification

Product Details

Model Numbers
Model Number: 722003
UDI-DI: N/A
Serial Numbers: 19
21
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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