Cardiovascular software recalled because it may display outdated information
IntelliSpace Cardiovascular software version 8.0.0.4 is recalled because of a software issue that results in the display of outdated information. 4 units are affected.
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 3/5 (High).
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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; clinical software that displays outdated information could inform a decision incorrectly, and no injuries are reported.
Plain-English summary
IntelliSpace Cardiovascular, software 8.0.0.4, model number 830089, UDI 00884838122000, is being recalled for serial numbers 2210, 2050, 463 and 193. The recall covers 4 units distributed in Georgia, North Carolina and Texas.
The recall was issued because of a software issue that results in the display of outdated information. The FDA classified the action as Class II.
Hospitals running this software version should follow the manufacturer's instructions for the correction.
The recalled product
- Product
- IntelliSpace Cardiovascular, Software 8.0.0.4.
- Manufacturer
- Philips Medical Systems Nederland B.V.
- Affected units
- 4
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
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