IntelliSpace Cardiovascular Software Echo Module Data Reporting Issue
Philips is recalling IntelliSpace Cardiovascular software versions 6.x, 7.x, and 8.x because the Echo Module may generate reports with missing or incomplete information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The source is a Class II medical device recall with no reported illnesses, injuries, or deaths. The hazard is incomplete or missing data in reports—a significant functional defect but not a direct patient safety threat, warranting a Moderate classification.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling IntelliSpace Cardiovascular (ISCV) software versions 6.x, 7.x, and 8.x (Model Number 830089) distributed domestically nationwide and internationally to multiple countries. An issue was identified with the software when using the Echo Module; the issue may result in missing or incomplete information in the report.
A total of 996 units have been distributed: 267 in the United States and 729 outside the United States. The affected software versions are identified by specific UDI-DIs and version numbers, including 6.1.0.0, 6.2.0.0, 7.0.0.0, 7.1.0.0, and 8.0.0.0.
Users should contact Philips Medical Systems Nederland B.V. for guidance on whether their systems are affected and for instructions on remediation or replacement.
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.
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.
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