# FDA recall Z-1926-2024

> **PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.** · Class II · device recall initiated 2024-05-02.

## Product

Philips Interventional Hemodynamic Application R.1.2X, R.1.3.0, R1.2.1. Software that enables invasive investigation of cardiac and vascular diseases.

## Reason for recall

Potential for pressure wave data synchronization from two devices may not be correct.

## Distribution

Worldwide distribution - US Nationwide in the states of CA, IN, OR and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Bulgaria, Chile, Costa Rica, C¿te D'Ivoire, Czech Republic, Ecuador, France, Germany, Gibraltar, Greece, Hungary, India, Ireland, Italy, Malaysia, Martinique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, R¿union, Russian Federation, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Sri Lanka, Switzerland, Thailand, Ukraine, United Kingdom.

## Key facts

- **Recall number:** Z-1926-2024
- **Recalling firm:** PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-02
- **Report date:** 2024-06-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Best, Netherlands

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1926-2024

## Citation

> AI Analytics. FDA recall Z-1926-2024. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1926-2024. Source: US FDA. Licensed CC0.

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