# FDA recall Z-1968-2026

> **Philips North America** · Class II · device recall initiated 2026-04-14.

## Product

Philips SmartPath to Ingenia Elition X with MR Elastography (MRE).     1. Model Number (REF): 782118.     2. Model Number (REF): 782144.      3. Model Number (REF): 782163.

## Reason for recall

The potential for stiffness value errors when a specific range of image reconstruction parameters is used in combination with Resoundant's algorithm, leading to the reconstruction voxel size settings in the default MRE scan protocol displaying too small.

## Distribution

Worldwide - US Nationwide and the countries of Argentina, Australia, Bangladesh, Belgium, Brazil, Canada, Chile, Cuba, Cyprus, Denmark, Ecuador, Egypt, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Iraq, Israel, Italy, Japan, Kenya, Lebanon, Lithuania, Malta, Mexico, Myanmar, Netherlands, Pakistan, Palestine, Peru, Poland, Portugal, Russian Fed., Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Kingdom.

## Key facts

- **Recall number:** Z-1968-2026
- **Recalling firm:** Philips North America
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-14
- **Report date:** 2026-05-06

- **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-1968-2026

## Citation

> AI Analytics. FDA recall Z-1968-2026. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1968-2026. Source: US FDA. Licensed CC0.

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