# FDA recall Z-2344-2021

> **Philips North America Llc** · Class II · device recall initiated 2021-07-30.

## Product

Ingenia Elition X-Magnetic Resonance Medical Electrical Systems indicated for use as a  diagnostic device. The system can produce cross-sectional images, spectroscopic images  and/or spectra in any orientation of the internal structure of the head, body or extremities  Model Number: 781358

## Reason for recall

Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury

## Distribution

Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO,  MD, MD, NH, NY, OH, TN, TX, VA and the countries of Canada, Mexico, Australia, Austria,  Chile, China, Czech Republic, Denmark, France, Germany, India, Indonesia, Italy, Japan,  Korea, Republic of Lebanon, Netherlands, Romania, Russian Federation, Saudi Arabia,  Spain, Turkey, Ukraine, United Kingdom.

## Key facts

- **Recall number:** Z-2344-2021
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-07-30
- **Report date:** 2021-09-01
- **Termination date:** 2023-07-25

- **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-2344-2021

## Citation

> AI Analytics. FDA recall Z-2344-2021. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2344-2021. Source: US FDA. Licensed CC0.

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