# FDA recall Z-1830-2024

> **Philips North America Llc** · Class II · device recall initiated 2024-04-22.

## Product

Ingenia 3.0T with Evolution Upgrade 3.0T - - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device  REF: 782117

## Reason for recall

Philips Ingenia Evolution systems with software R5.7.1 may not provide warning for low ventilation setting which may lead to increase in body temperature or burning sensation

## Distribution

Worldwide - US Nationwide distribution in the states of CA, KS, MS, NH and the countries of Austria, Croatia, Finland, France, Germany, Italy, Lebanon, Netherlands, Norway, Sweden, Switzerland, Thailand, United Kingdom.

## Key facts

- **Recall number:** Z-1830-2024
- **Recalling firm:** Philips North America Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-22
- **Report date:** 2024-05-22

- **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-1830-2024

## Citation

> AI Analytics. FDA recall Z-1830-2024. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1830-2024. Source: US FDA. Licensed CC0.

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