HIGH

Philips Medical Systems Recalls Allura Xper FD10 Over Battery Issue

Philips Medical Systems recalled 2,317 Allura Xper FD10 systems on September 3, 2025. The BIOS battery may deplete faster than expected, halting the system startup. Affected models include 722003, 722010, and 722026.

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 FD10 diagnostic imaging system. Model numbers include 722003, 722010, and 722026. The systems were distributed worldwide, including 497 units in the U.S. and 1,820 units internationally.

The Hazard

The BIOS battery in these systems may deplete faster than anticipated. When the battery is depleted, the system will not start, and users receive no prior warning.

Reported Incidents

No specific incidents or injuries have been reported related to this issue. The potential for system failure poses significant risks during medical procedures.

What to Do

Stop using the Allura Xper FD10 immediately. Follow recall instructions provided by the manufacturer and contact Philips Medical Systems for further guidance.

Contact Information

For assistance, contact Philips Medical Systems Nederland B.V. or your healthcare provider. Additional details are available at the recall notification link.

Key Facts

  • Recall date: September 3, 2025
  • Report date: October 8, 2025
  • Quantity recalled: 2,317 units
  • No reported injuries or deaths
  • Worldwide distribution including the U.S.

Safety Assessment

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

Product Classification

Product TypeDiagnostic Imaging System
Sold At
Multiple Retailers

Product Details

Model Numbers
Model Numbers: (1) 722003
(2) 722010
(3) 722026
UDI-DI: (1) N/A
(2) 00884838059030
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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