Company: Philips Medical Systems Nederland B.V.
Date of Enforcement Report: 2/28/2025
Class II
PRODUCT
Philips IntelliSpace Cardiovascular software, Model 830089.
Recall Number:
Z-1252-2025
REASON:
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
RECALLING FIRM/MANUFACTURER:
Philips Medical Systems Nederland B.V.
VOLUME OF PRODUCT IN COMMERCE:
139
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.
