IntelliSpace Cardiovascular 9Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838125773), received between Sep 25, 2026 and Sep 25, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Computer System Security Problem” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2026Computer System Security Problem

  Philips identified an internal software defect in the IntelliSpace Cardiovascular (ISCV) system whereby Server Message Block (SMB) signing is not mandatorily enforced on remote hosts. There is no allegation of death, serious injury, or adverse event associated with this issue.This security weakness could allow an attacker with prior access to the ISCV network to intercept or manipulate communications between systems, potentially leading to unauthorized access to sensitive patient information (PHI/PII), modification of image repository files, or other unauthorized file operations. Under certain circumstances, compromised medical images or patient data could be relied upon for clinical decision-making, potentially resulting in misdiagnosis, delayed or missed critical findings.Therefore, although the issue was identified internally and exploitation requires prior network access, the potential impact on the integrity of diagnostic information and subsequent clinical decision-making supports classification of this issue as a reportable malfunction.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50897781 ↗