Philips Medical Systems Nederland B.V.: Medical Device Recall in 2025 - (Recall #: Z-1252-2025)

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:

Philips IntelliSpace Cardiovascular software, Model 830089.

Product Classification:

Class II

Date Initiated: April 4, 2024

Date Posted: March 12, 2025

Recall Number: Z-1252-2025

Event ID: 96129

Reason for Recall:

Study data is not able to be archived, copied, or exported with the cardiovascular software version.

Status: Ongoing

Product Quantity: 139

Code Information:

Software version 7.0.0.0, UDI (01)00884838115378(11)221214(10)7.0.0.0.

Distribution Pattern:

US Nationwide distribution in the states of AK, AL, AZ, CA, CT, FL, GA, IA, IN, KY, MA, MI, MN, NC, NE, NY, OH, OR, TN, TX, VA, and WI. There was government distribution but no military distribution.

Voluntary or Mandated:

Voluntary: Firm initiated