FDA-Device2025-03-12Class II
Philips IntelliSpace Cardiovascular software, Model 830089.
Hazard
Study data is not able to be archived, copied, or exported with the cardiovascular software version.
Sold states
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.
Affected count
139
Manufactured in
High Tech Campus 36, Eindhoven, Netherlands
Products
Philips IntelliSpace Cardiovascular software, Model 830089.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1252-2025More Philips Medical Systems Nederland B.V. recalls
- FDA-Device2026-06-03Philips Azurion imaging systems recalled for hard drive failure risk affecting imaging functionality
- FDA-Device2026-06-03Philips Allura medical imaging systems recalled for hard drive failure risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for cooling hose degradation risk
- FDA-Device2026-05-27Philips Integris-Allura X-ray systems recalled for cooling unit oil leakage risk
- FDA-Device2026-05-27Philips Azurion X-ray systems recalled for impaired table movement due to control wear
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