Philips Medical Systems Nederland B.V.: Device Recall

Recall #Z-2543-2025 · 08/08/2025

Class II: Risk

Recall Details

Recall Number: Z-2543-2025
Classification: Class II
Product Type: Device
Recalling Firm: Philips Medical Systems Nederland B.V.
Status: Ongoing
Date Initiated: 08/08/2025
Location: Eindhoven, N/A, Netherlands
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4 units

Reason for Recall

Software issue that results in the display of outdated information.

Product Description

IntelliSpace Cardiovascular, Software 8.0.0.4.

Distribution Pattern

US Nationwide distribution in the states of GA, NC & TX.

Other Recalls by Philips Medical Systems Nederland B.V.

Class II: Risk 12/15/2025

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II: Risk 12/15/2025

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II: Risk 12/15/2025

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II: Risk 12/15/2025

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.
Class II: Risk 12/15/2025

Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown.

View all recalls by Philips Medical Systems Nederland B.V. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.