Philips Medical Systems Nederland B.V.: Medical Device Recall in 2025 - (Recall #: Z-2543-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

IntelliSpace Cardiovascular, Software 8.0.0.4.

Product Classification:

Class II

Date Initiated: August 8, 2025

Date Posted: September 17, 2025

Recall Number: Z-2543-2025

Event ID: 97379

Reason for Recall:

Software issue that results in the display of outdated information.

Status: Ongoing

Product Quantity: 4 units

Code Information:

Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated