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)8.0.0.0
    • Serial No. 2210
    • 2050
    • 463
    • 193
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Software issue that results in the display of outdated information.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.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Philips Medical Systems Nederland B.V. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 7:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.