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Philips Medical Systems Nederland B.V. recalls Philips IntelliSpace Cardiovascular software, Model 830089.
Recalled March 12, 2025 · FDA recall Z-1252-2025 · Philips Medical Systems Nederland B.V
Hazard
Study data is not able to be archived, copied, or exported with the cardiovascular software version. · FDA Class II
Units
139
Sold at
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.
Description
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Product
Philips IntelliSpace Cardiovascular software, Model 830089.
Manufacturer(s)
Philips Medical Systems Nederland B.V.
Made in
Netherlands
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →