# FDA recall Z-1041-2022

> **Philips North America Llc** · Class II · device recall initiated 2022-02-22.

## Product

Philips Hemodynamic Application, Model Number 722463, Software Version Number: R1.2.2 and R1.2.3.  For visualization and analysis of patient hemodynamic data in the Philips Interventional Hemodynamic System.

## Reason for recall

When a Neonatal patient is admitted, the Non-Invasive Blood Pressure is not set to Neonatal mode on the Philips Xperflex Cardio FC2010 patient monitor.  If the NIBP is not set to Neonatal, the cuff inflation pressure applied will be higher than 150 mmHg and the deflation pressure will be higher than 5 mmHg.  An applied cuff inflation pressure higher than 150mmHg or a deflation pressure higher than 5 could lead to bruising, mmHg nerve damage or bone deformity for a neonate.

## Distribution

Devices were distributed to the following US states: FL, ID, NJ, OK, SC and TX.  Devices were distributed to the following foreign countries: France, Germany, India, Mexico, Netherlands,  New Zealand, Norway, Poland, South Africa, and Switzerland.

## Key facts

- **Recall number:** Z-1041-2022
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2022-02-22
- **Report date:** 2022-05-18
- **Termination date:** 2024-11-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cambridge, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1041-2022

## Citation

> AI Analytics. FDA recall Z-1041-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1041-2022. Source: US FDA. Licensed CC0.

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