# FDA recall Z-1044-2026

> **GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING** · Class II · device recall initiated 2025-12-10.

## Product

SMV DSX New Line,     System, Tomography, Computed, Emission

## Reason for recall

GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as  Impacted Systems  and  listed in the Affected Product Details section of this letter) 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.    There have been no reports of detector falls or injuries as a result of this potential issue.    The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.

## Distribution

US, Brazil, Egypt, Canada, Mexico, Turkey, Italy, Sweden, Switzerland, France, Spain Chile, Germany, Iran, Greece

## Key facts

- **Recall number:** Z-1044-2026
- **Recalling firm:** GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-10
- **Report date:** 2026-01-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1044-2026

## Citation

> AI Analytics. FDA recall Z-1044-2026. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1044-2026. Source: US FDA. Licensed CC0.

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