FDA Medical devices recall ·
IntelliSpace Cardiovascular, Software 8.0.0.4 recall
- Recall number
- Z-2543-2025
- Date
- (initiated August 8, 2025)
- Company / brand
- Philips Medical Systems Nederland B.V.
High Tech Campus 36, Eindhoven, N/A, Netherlands - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 4 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
IntelliSpace Cardiovascular, Software 8.0.0.4.
Why was it recalled?
Software issue that results in the display of outdated information.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model No. 830089; UDI: (01)00884838122000(11)240325(10)8.0.0.0; Serial No. 2210, 2050, 463, 193.
Distribution
US Nationwide distribution in the states of GA, NC & TX.
States: Georgia North Carolina Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2543-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.