Company: Philips Medical Systems Nederland B.V
Date of Enforcement Report: 5/8/2025
Class II
PRODUCT
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Recall Number:
Z-1740-2025
REASON:
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.
RECALLING FIRM/MANUFACTURER:
Philips Medical Systems Nederland B.V
VOLUME:
1,004 units (246 US, 758 OUS)
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.
