PlainRecalls
FDA Devices Moderate Class II Ongoing

IntelliSpace Cardiovascular, Software 8.0.0.4.

Reported: September 17, 2025 Initiated: August 8, 2025 #Z-2543-2025

Product Description

IntelliSpace Cardiovascular, Software 8.0.0.4.

Reason for Recall

Software issue that results in the display of outdated information.

Details

Units Affected
4 units
Distribution
US Nationwide distribution in the states of GA, NC & TX.
Location
Eindhoven, N/A

Frequently Asked Questions

What product was recalled?
IntelliSpace Cardiovascular, Software 8.0.0.4.. Recalled by Philips Medical Systems Nederland B.V.. Units affected: 4 units.
Why was this product recalled?
Software issue that results in the display of outdated information.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 17, 2025. Severity: Moderate. Recall number: Z-2543-2025.