IntelliSpace Cardiovascular recall: Software Issue
IntelliSpace Cardiovascular, Software 8.0.0.4.
Why was IntelliSpace Cardiovascular recalled?
Software issue that results in the display of outdated information.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
- Product
- IntelliSpace Cardiovascular, Software 8.0.0.4.
- Recalling firm
- Philips Medical Systems Nederland B.V.
- Quantity
- 4 units
- Distribution
- US Nationwide distribution in the states of GA, NC & TX.
- Recall date
- September 17, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)