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

Philips IntelliSpace Cardiovascular Software Versions 6-8 Recall

Philips is recalling IntelliSpace Cardiovascular software versions 6.x-8.x due to a bug that may cause incomplete or missing diagnostic information in reports. The issue affects 996 units distributed globally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving software that may produce incomplete diagnostic information in cardiovascular reports. No injuries or illnesses reported. Theoretical harm without reported incidents scores 3 per rubric.

Plain-English summary

Philips Medical Systems Nederland B.V. is recalling IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x (Model Number 830089). This diagnostic software is used for cardiovascular imaging and analysis.

A software issue was identified in the Echo Module that may result in missing or incomplete information in diagnostic reports generated by the system.

The recall impacts 996 units distributed globally: 267 units in the United States (nationwide distribution) and 729 units internationally across countries including 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, and the United Kingdom.

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 Imaging Software
Hazard
  • incomplete-data
  • software-malfunction

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