Medical Device Recall: IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Philips Medical Systems Nederland B.V. · April 7, 2025
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
996 units (267 US, 729 OUS)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1740-2025
Status: ongoing
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