The Recall Desk
ModerateFDA (Devices)·Z-1252-2025·Announced 2025-03-12

Philips IntelliSpace Cardiovascular Software Data Archival Failure Recall

Philips cardiovascular diagnostic software version 7.0.0.0 cannot archive, copy, or export study data, affecting 139 units distributed nationwide. Users may experience data management and workflow disruptions.

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: This Class II recall involves a data management defect with no reported illnesses, injuries, or hospitalizations. The hazard is operational rather than directly patient safety-related, affecting the ability to archive, copy, or export study data.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling Philips IntelliSpace Cardiovascular software, Model 830089, software version 7.0.0.0 due to a data management defect. The software is unable to archive, copy, or export study data, which prevents proper data management and workflow operations.

This recall affects 139 units of the software distributed nationwide across 21 U.S. states: Alaska, Alabama, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Kentucky, Massachusetts, Michigan, Minnesota, North Carolina, Nebraska, New York, Ohio, Oregon, Tennessee, Texas, Virginia, and Wisconsin.

Users should discontinue use of version 7.0.0.0 if they rely on data archival, copying, or export functions. Contact Philips Medical Systems Nederland B.V. for software updates or patches that address this data management issue.

No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Philips IntelliSpace Cardiovascular software, Model 830089.
Manufacturer
Philips Medical Systems Nederland B.V.
Category
Medical Device — Cardiovascular Software
Hazard
Affected units
139

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 (2)

  • Software version 7.0.0.0
  • UDI (01)00884838115378(11)221214(10)7.0.0.0.

Distribution

Distributed nationwide across the United States.

The notice also names 22 states specifically:

Related recalls

Same manufacturer · Philips Medical Systems Nederland B.V.

See all →