CLASS II ONGOING Device recall · Reported 17 Sep 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 8 Aug 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-2543-2025
- FDA event ID
- 97379
- Recalling firm
- Philips Medical Systems Nederl, Eindhoven, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Aug 2025
- FDA classified
- 9 Sep 2025
- Reported
- 17 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 8 Aug 2025 | Recall initiated by company | |
| 9 Sep 2025 | Classified by FDA | +32 days |
| 17 Sep 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Software issue that results in the display of outdated information.
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 8.0.0.4.
Where it was distributed
US Nationwide distribution in the states of GA, NC & TX.
Questions about this recall
Why was it recalled?
Software issue that results in the display of outdated information.
Which lots are affected?
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
Where was it sold?
US Nationwide distribution in the states of GA, NC & TX.
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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