# FDA recall Z-1264-2019

> **GE Healthcare, LLC** · Class II · device recall initiated 2019-03-20.

## Product

NM/CT 870 CZT, Model/Catalogue/Code # H3906CW    Product Usage:  The GE Discovery NM/CT 670 CZT system is intended for general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine system using a variety of scanning modes supported by various acquisition types, and a Computed Tomography system which is intended for enabling attenuation correction and anatomical localization of SPECT images and for standalone head, whole body, cardiac and vascular X-ray Computed Tomography applications.

## Reason for recall

During installation of certain Nuclear Medicine systems delivered with dismounted detectors, some detector screws may not have been secured correctly, leading to the possible loss of one detector mounting design redundancy.

## Distribution

US and Austria, Canada, Croatia, France, Germany, India, Italy, Japan, Republic of Korea, Netherlands, Poland, Portugal, Slovakia, South Africa, Spain, Sweden, Switzerland, UK

## Key facts

- **Recall number:** Z-1264-2019
- **Recalling firm:** GE Healthcare, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-03-20
- **Report date:** 2019-05-08
- **Termination date:** 2020-10-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukesha, WI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1264-2019

## Citation

> AI Analytics. FDA recall Z-1264-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1264-2019. Source: US FDA. Licensed CC0.

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