CLASS II ONGOING Device recall · Reported 14 May 2025 · FDA Enforcement Report
IntelliSpace Cardiovascular recalled by Philips Medical Systems
Philips Medical Systems Nederl is recalling IntelliSpace Cardiovascular, distributed nationwide in the US. The recall was initiated on 7 Apr 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1740-2025
- FDA event ID
- 96377
- Recalling firm
- Philips Medical Systems Nederl, Eindhoven, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Apr 2025
- FDA classified
- 8 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 7 Apr 2025 | Recall initiated by company | |
| 8 May 2025 | Classified by FDA | +31 days |
| 14 May 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Where it was distributed
Domestic: Nationwide Distribution International: 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, United Kingdom.
Questions about this recall
Why was it recalled?
An issue was identified with the software when using the Echo Module of ISCV, the issue may result in missing or incomplete information in the report.
Which lots are affected?
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).
Where was it sold?
Domestic: Nationwide Distribution International: 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, United Kingdom.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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