# FDA recall Z-2097-2025

> **GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING** · Class II · device recall initiated 2025-06-20.

## Product

Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system

## Reason for recall

Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-2097-2025
- **Recalling firm:** GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-06-20
- **Report date:** 2025-07-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tirat Carmel, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2097-2025

## Citation

> AI Analytics. FDA recall Z-2097-2025. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-2097-2025. Source: US FDA. Licensed CC0.

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