Reported May 14, 2025 · Ongoing
IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x; Model Number: 830089.
Philips Medical Systems Nederland B.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Philips Medical Systems Nederland B.V. · High Tech Campus 36 · Eindhoven, N/A · N/A
Is this the product you have?
- IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x
- Model Number830089
- Lot codes and dates
3 of 3 products
Products covered by this recall Model / number Barcodes Product as published 830089— — Software Versions: 6x, 7.x, and 8.x — 0088483810697000884838106970008848381153780088483811537800884838122000UDI-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). - Amount recalled
- 996 units (267 US, 729 OUS)
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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