HIGH

Philips Cardiac Workstation 5000 860439 Recalled After Pinched Wire Causes Short, 28 Units in U.S.

Philips North America recalls 28 Cardiac Workstation 5000 devices, model 860439, distributed nationwide in five states. A pinched power module wire led to a short during environmental stress tests. Users should stop using the device and follow manufacturer recall instructions.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brand
Philips North America
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, ELDERLY

Hazard Information

Failure of Environmental Stress Testing from a pinched power module wire within the housing of the Cardiac Workstation device which resulted in a short.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Philips North America or your healthcare provider for instructions. Notification method: Letter

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About This Product

Cardiac Workstation 5000 is a medical device used in clinical settings for cardiac monitoring and data processing.

Why This Is Dangerous

Pinched wire can cause a short circuit, potentially impacting device function during testing or use.

Industry Context

This recall is part of a broader pattern of medical device electrial safety recalls.

Real-World Impact

No injuries reported yet; device shut-down risk could disrupt clinical workflows and patient monitoring.

Practical Guidance

How to identify if yours is affected

  1. Check model number 860439 on the device label.
  2. Confirm UDI-DI 00884838094826.
  3. Review recall notice for serial numbers and affected lots.

Where to find product info

FDA recall page and Philips North America recall site.

What timeline to expect

Refunds or replacements are coordinated through Philips; timelines vary by case.

If the manufacturer is unresponsive

  • Document all contacts
  • Escalate to FDA or seek legal counsel if unresponsive

How to prevent similar issues

  • Ensure devices are regularly inspected for cord and housing integrity.
  • Follow manufacturer's maintenance schedules.
  • Register devices with Philips for service alerts.

Documentation advice

Keep recall correspondence, photos of the device, and serial numbers.

Product Details

Model Number: 860439. Distribution: US nationwide in CA, IA, TN, TX, VA. Quantity: 28 units. Brand: Philips North America. Category: Medical Devices.

Reported Incidents

No specific injuries or incidents are mentioned in the provided data.

Key Facts

  • 28 units recalled
  • Model 860439
  • UD I-DI: 00884838094826
  • Recall date 2025-09-12
  • Status: ACTIVE
  • Hazard level HIGH

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTELDERLYPREGNANTPETS
Injury Types
ELECTRICALOTHER

Product Details

Model Numbers
860439
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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