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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Philips North America
- Product type
- Cardiac Workstation
- Model numbers
- 860439
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 12, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check model number 860439 on the device label.
- 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.
- Register devices with Philips for service alerts.
Documentation advice
Keep recall correspondence, photos of the device, and serial numbers.
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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
- Hazard level HIGH
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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