FDAFDA · Food and drugs·Recall number Z-2543-2025
IntelliSpace Cardiovascular, Software 8.0.0.4.
Published September 17, 2025 · Recall initiated: August 8, 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
Software issue that results in the display of outdated information.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Distributor
- US Nationwide distribution in the states of GA, NC & TX.
- Lot
- Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Netherlands
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