FDA-Device2025-05-14Class II
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Philips Medical Systems Nederland B.V.
Hazard
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Sold states
Domestic: Nationwide Distribution International: Australia, Austria, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Indonesia, Ireland, Italy, Japan, Luxembourg, Mexico, Netherlands, Norway, Poland, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Thailand, United Kingdom.
Affected count
996 units (267 US, 729 OUS)
Manufactured in
High Tech Campus 36, N/A, Eindhoven, N/A, Netherlands
Products
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1740-2025Don't want to check this manually?
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