Class II

Medical Device Recall: Philips IntelliSpace Cardiovascular software, Model 830089.

Philips Medical Systems Nederland B.V. · April 4, 2024

Reason for Recall

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

Distribution

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.

States Affected

NATIONWIDE

Quantity Affected

139

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1252-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Philips Medical Systems Nederland B.V. Medical Device Recall: Philips IntelliSpace Cardiovascular software, Model 830089. | SafeCheck