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Philips Medical Systems Nederland B.V. recalls IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Recalled May 14, 2025 · FDA recall Z-1740-2025 · 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. · FDA Class II
Units
996 units (267 US, 729 OUS)
Sold at
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.
Description
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.
Product
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 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 →