# FDA recall Z-1265-2019

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

## Product

NM/CT 870 DR    Product Usage:  The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained health professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.  The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.  The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce

## 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-1265-2019
- **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-1265-2019

## Citation

> AI Analytics. FDA recall Z-1265-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1265-2019. Source: US FDA. Licensed CC0.

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