Safety Alert: Class II: Software issue that results in the display of outdated information.
healthClass IIRecalled on Sep 17, 2025
IntelliSpace Cardiovascular, Software 8.0.0.4.
🔢 4 units
Sold At: Philips Medical Systems Nederland B.V.(US Nationwide distribution in the states of GA, NC & TX.)
Recall #: FDA-DEVICE-Z-2543-2025
Source: FDA-ENFORCEMENT
Product Identification
- Lot/Batch Codes:
- Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
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Summary
Software issue that results in the display of outdated information.
What to do next
- 1Stop using this product - may cause temporary or medically reversible health problems
- 2Check with retailer or manufacturer for recall status and remedy options
- 3Contact Philips Medical Systems Nederland B.V. for return or refund information
- 4Visit the official FDA recall page for complete details
Summaries only; always follow the official notice.