FDA recall Z-1740-2025

Philips Medical Systems Nederland B.V. · Class II · device

Product

IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.

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.

Key facts

Status: Ongoing
Initiation date: 2025-04-07
Report date: 2025-05-14
Voluntary/Mandated: Voluntary: Firm initiated
Location: Eindhoven, N/A, Netherlands

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1740-2025