The Recall Desk
ModerateFDA (Devices)·Z-1740-2025·Announced 2025-05-14

IntelliSpace Cardiovascular Software Echo Module Data Reporting Issue

Philips is recalling IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x because the Echo Module may generate reports with missing or incomplete information.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source is a Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard is incomplete or missing data in reports—a significant functional defect but not a direct patient safety threat, warranting a Moderate classification.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling IntelliSpace Cardiovascular (ISCV) software versions 6.x, 7.x, and 8.x (Model Number 830089) distributed domestically nationwide and internationally to multiple countries. An issue was identified with the software when using the Echo Module; the issue may result in missing or incomplete information in the report.

A total of 996 units have been distributed: 267 in the United States and 729 outside the United States. The affected software versions are identified by specific UDI-DIs and version numbers, including 6.1.0.0, 6.2.0.0, 7.0.0.0, 7.1.0.0, and 8.0.0.0.

Users should contact Philips Medical Systems Nederland B.V. for guidance on whether their systems are affected and for instructions on remediation or replacement.

The recalled product

Product
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Manufacturer
Philips Medical Systems Nederland B.V.
Category
Medical Device — Cardiovascular Software
Hazard
  • data-integrity
  • incomplete-reporting

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • Model Number: 830089
  • Software Versions: 6x
  • 7.x
  • and 8.x
  • UDI-DIs: (01)00884838106970(11)211130(10)6.1.0.0 (Version 6.1.0.0)
  • (01)00884838106970(11)220623(10)6.2.0.0 (Version 6.2.0.0)
  • (01)00884838115378(11)221214(10)7.0.0.0 (Version 7.0.0.0)
  • (01)00884838115378(11)230711(10)7.1.0.0 (Version 7.1.0.0)
  • (01)00884838122000(11)240325(10)8.0.0.0 (Version 8.0.0.0).

Distribution

Distributed nationwide across the United States.

Related recalls

Same category