What model numbers are affected by this recall?

Affected models are 722003, 722010 and 722026. Serial numbers listed include 1343, 1349, 1153, 1154, 1472, 257, 1694, 746, 745, 1599, 501, 503, 1360, 959.

What is the hazard associated with this recall?

The BIOS battery may deplete faster than anticipated, causing the startup process to halt and the system to fail to start. No user messages appear before power depletion.

How many units are involved and where were they sold?

2,317 units were distributed worldwide, including 497 in the US and 1,820 outside the US.

What should hospitals do now?

Stop using the affected devices and follow the recall instructions from the manufacturer. Notify relevant clinical engineering teams and hospital risk managers.

Who should be contacted for instructions?

Healthcare facilities should contact Philips Medical Systems Nederland B.V. for remediation instructions or the hospital’s designated service provider.

Is there a consumer refund?

This recall involves hospital equipment, not consumer retail sales. Follow manufacturer instructions for service or replacement as directed.

What information should facilities gather?

Model numbers, serial numbers, UDI details, and the number of affected devices in the facility.

How long will remediation take?

Remediation timelines vary by site. Hospitals should expect coordination with the manufacturer to determine service or replacement options.

Where can I find official recall documentation?

Refer to the FDA recall enforcement page linked to the Z-0002-2026 recall notice.

What if the facility cannot reach the manufacturer quickly?

Escalate to hospital risk management and consider filing a report with health authorities if needed. Maintain documentation of all outreach.

HIGHSeptember 3, 2025

Philips Allura Xper FD10 Recalled for BIOS Battery Startup Failure (2,317 Units Worldwide, 2025)

Philips Medical Systems Nederland recalled 2,317 Allura Xper FD10 imaging systems worldwide, including 497 in the United States. The BIOS battery may deplete faster than expected, causing the startup process to halt with no user alerts. Hospitals should stop using the devices and await manufacturer instructions.

Quick Facts at a Glance

Recall Date: September 3, 2025
Hazard Level: HIGH
Brand: Philips Medical Systems Nederland
Category: Health & Personal Care
Sold At: Unknown
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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About This Product

Allura Xper FD10 is a medical imaging system used in interventional radiology to guide procedures. Hospitals purchase these units for advanced imaging during cardiac and vascular interventions.

Why This Is Dangerous

A BIOS battery that depletes faster than expected can prevent the system from starting. There are no user alerts prior to power depletion, delaying diagnosis of the issue.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals may face unexpected downtime and service disruptions, potentially delaying patient procedures and requiring temporary equipment substitution.

Practical Guidance

How to identify if yours is affected

Check model numbers against 722003, 722010, 722026.
Verify serial numbers against the list provided: 1343, 1349, 1153, 1154, 1472, 257, 1694, 746, 745, 1599, 501, 503, 1360, 959.
Look up UDI-DI values: 00884838059030 for 722010 and 00884838054189 for 722026; 722003 has N/A.

Where to find product info

Check device label, service records, or hospital inventory system for model, serial, and UDI codes.

What timeline to expect

Remediation timelines vary by site; expect several weeks to coordinate replacement or service.

If the manufacturer is unresponsive

Document all outreach attempts to Philips and the hospital’s risk management team.
If necessary, file concerns with appropriate health authorities and maintain records of communications.

How to prevent similar issues

Register for recall alerts from Philips and FDA.
Maintain current inventory logs with model, serial, and UDI codes.
Establish a clear escalation path with hospital engineering and risk management.

Documentation advice

Keep copies of recall notices, correspondence with the manufacturer, service reports, and serial/UDI documentation for each device.

Product Details

Model numbers: 722003, 722010, 722026. Associated 510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563. Serial numbers include 1343, 1349, 1153, 1154, 1472, 257, 1694, 746, 745, 1599, 501, 503, 1360, 959. UDI-DI: 00884838059030 (model 722010), 00884838054189 (model 722026), 1 N/A (model 722003). Quantity: 2317 units (497 US, 1820 outside US). Distribution: Worldwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

2,317 total units recalled (US 497; international 1,820)
Model numbers: 722003, 722010, 722026
510(k) numbers: K102005, K130638, K130842, K133292, K141979, K162859, K161563
Serial numbers include 1343, 1349, 1153, 1154, 1472, 257, 1694, 746, 745, 1599, 501, 503, 1360, 959
Broadcast distribution: Worldwide

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

5/ 10

Affected Groups

GENERAL

Injury Types

OTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeMedical Imaging System

Product Details

Sep 3, 2025

Philips Medical Systems Nederland

The BIOS