# FDA recall Z-2543-2025

> **Philips Medical Systems Nederland B.V.** · Class II · device recall initiated 2025-08-08.

## Product

IntelliSpace Cardiovascular, Software 8.0.0.4.

## Reason for recall

Software issue that results in the display of outdated information.

## Distribution

US Nationwide distribution in the states of GA, NC & TX.

## Key facts

- **Recall number:** Z-2543-2025
- **Recalling firm:** Philips Medical Systems Nederland B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-08-08
- **Report date:** 2025-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Eindhoven, N/A, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2543-2025

## Citation

> AI Analytics. FDA recall Z-2543-2025. Retrieved 2026-09-07 from https://api.ai-analytics.org/recall/Z-2543-2025. Source: US FDA. Licensed CC0.

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