HIGH

Philips Medical Systems Recalls Cardiac Monitor Over Battery Issue

Philips Medical Systems recalled 313 cardiac monitors on September 3, 2025, due to a BIOS battery issue. The battery may deplete unexpectedly, halting the device's start-up process without warning. Patients and healthcare providers must stop using the device 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

Model number 722400 is affected by this recall. The device is distributed worldwide, including the US and various countries across Europe, Asia, and South America. The quantity recalled is 313 units.

The Hazard

The BIOS battery in the cardiac monitor may deplete faster than expected. When depleted, the system will not start, potentially putting patients at risk.

Reported Incidents

There are no reported incidents of injury or death associated with this recall. However, the lack of user notifications about battery depletion raises serious safety concerns.

What to Do

Stop using the cardiac monitor immediately. Follow the manufacturer's recall instructions and contact Philips Medical Systems for further guidance.

Contact Information

For more information, contact Philips Medical Systems Nederland B.V. or visit the recall page at the FDA's website.

Key Facts

  • 313 units recalled worldwide
  • Potential for device failure during operation
  • Immediate action required from users
  • Contact Philips for further instructions

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Safety Assessment

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

Product Details

Model Numbers
Model Numbers: 722400
UDI-DI: N/A
Serial Numbers: 282
91
206
+15 more
Affected States
ALL
Report Date
October 8, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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