FDAFDA · Food and drugs·Recall number Z-0165-2026
Cardiac Workstation 5000; Model Number: 860439;
Published October 22, 2025 · Recall initiated: September 12, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips North America
- Distributor
- US Nationwide distribution in the states of CA, IA, TN, TX, VA.
- Lot
- Model Number: 860439; UDI-DI: 00884838094826; Serial Numbers:
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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