Reported Sep 17, 2025 · Ongoing
IntelliSpace Cardiovascular, Software 8.0.0.4.
Philips Medical Systems Nederland B.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Nederland B.V. · High Tech Campus 36 · Eindhoven, N/A · N/A
Is this the product you have?
- IntelliSpace Cardiovascular, Software 8.0.0.4.
- Lot codes and dates
- Model No. 830089
- UDI
(01)00884838122000(11)240325(10)8.0.0.0Serial No. 22102050463193
- Amount recalled
- 4 units
Where it was sold
Why it was recalled
Software issue that results in the display of outdated information.
This product could cause temporary or reversible health problems — stop using it.
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