# FDA recall Z-2398-2023

> **Philips North America** · Class II · device recall initiated 2023-06-12.

## Product

Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)

## Reason for recall

During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.

## Distribution

US Nationwide. Global Distribution.

## Key facts

- **Recall number:** Z-2398-2023
- **Recalling firm:** Philips North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-12
- **Report date:** 2023-08-16

- **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-2398-2023

## Citation

> AI Analytics. FDA recall Z-2398-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2398-2023. Source: US FDA. Licensed CC0.

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