Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
- Recall date
- April 7, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1740-2025
- FDA classification
- Class II
- Brand / firm
- Philips Medical Systems Nederland B.V.
- Sold / distributed
- 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, U…
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
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