Philips IntelliSpace Cardiovascular Software displays outdated clinical information
Philips IntelliSpace Cardiovascular Software 8.0.0.4 displays outdated information due to a software issue. Four units are distributed nationwide across Georgia, North Carolina, and Texas.
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: This is an FDA Class II medical device recall involving a cardiovascular system. The hazard—display of outdated information—represents a risk-of-harm scenario where potential injury has not yet been reported. In a clinical cardiovascular context, displaying outdated information could affect clinical decision-making.
Plain-English summary
Philips Medical Systems Nederland B.V. is recalling IntelliSpace Cardiovascular Software 8.0.0.4 due to a software issue that results in the display of outdated information.
Four units with serial numbers 2210, 2050, 463, and 193 are affected. The affected units have been distributed nationwide in Georgia, North Carolina, and Texas.
The recalled product
- Product
- IntelliSpace Cardiovascular, Software 8.0.0.4.
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Hazard
- outdated-information
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 (6)
- Model No. 830089
- UDI: (01)00884838122000(11)240325(10)8.0.0.0
- Serial No. 2210
- 2050
- 463
- 193.
Distribution
Distributed nationwide across the United States.
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