MAUDE adverse event: Philips Medical Systems Nederland B.V. - IntelliSpace Cardiovascular

Reported to the FDA Oct 28, 2026 (event Jul 1, 2026). The FDA publishes these reports weeks after receipt. Philips identified a software defect internally in Intellispace Cardiovascular (ISCV) wherein the ISCV is shipped with unsigned binaries, installers, and scripts. The device was ou