# FDA recall Z-0889-2025

> **GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING** · Class II · device recall initiated 2024-12-18.

## Product

GE Healthcare Brivo NM 615, Model/Catalog Numbers:    1) 5376204-15,   2) H2401MA,   3) H3100TA; System, Tomography, Computed, Emission

## Reason for recall

GE HealthCare has become aware that certain Infinia, VariCam/VG/VH, Brivo NM 615, Discovery NM 630, Discovery NM/CT 670, and Optima NM/CT 640 Nuclear Medicine systems (see Affected Products Details and Appendices) could have been transported or relocated without proper detector support, which can result in excessive load being applied to the detector mounting mechanisms. 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-0889-2025
- **Recalling firm:** GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-18
- **Report date:** 2025-01-22

- **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-0889-2025

## Citation

> AI Analytics. FDA recall Z-0889-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0889-2025. Source: US FDA. Licensed CC0.

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