# FDA recall Z-0293-2026

> **GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING** · Class II · device recall initiated 2025-09-12.

## Product

Elscint SPX6; dual-head nuclear medicine gamma camera designed specifically for cardiac imaging

## Reason for recall

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury.

## Distribution

Worldwide

## Key facts

- **Recall number:** Z-0293-2026
- **Recalling firm:** GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-09-12
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Haifa, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0293-2026

## Citation

> AI Analytics. FDA recall Z-0293-2026. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0293-2026. Source: US FDA. Licensed CC0.

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