HIGH

Philips Medical Systems Recalls Allura Xper FD20/20 Over Battery Issues

Philips Medical Systems Nederland B.V. recalled 115 Allura Xper FD20/20 medical imaging devices on September 3, 2025. The BIOS battery may deplete faster than expected, halting the system during startup. The recall affects 34 devices in the U.S. and 81 internationally.

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 Allura Xper FD20/20 has model number 722038. It was distributed worldwide, including in the U.S. and over 80 other countries. The total quantity recalled is 115 units.

The Hazard

The BIOS battery in the Allura Xper FD20/20 may deplete faster than anticipated. If the battery depletes, the system will not start, posing a risk to patient care.

Reported Incidents

There are no reported injuries associated with this recall. Users have not received any warning messages before the battery depletes.

What to Do

Patients and healthcare providers must stop using the Allura Xper FD20/20 immediately. Follow the recall instructions from Philips Medical Systems for further action.

Contact Information

Contact Philips Medical Systems Nederland B.V. for more information on the recall. Visit the FDA website for further details.

Key Facts

  • 115 units recalled
  • No reported injuries
  • Immediate cessation of use advised
  • Worldwide distribution

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Model Numbers: 722038
UDI-DI: 00884838054226
Serial Numbers: 39
63
42
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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