# FDA recall Z-1266-2019

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

## Product

Optima NM/CT 640    Product Usage:  The GE Optima NM/CT 640 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 (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies.

## 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-1266-2019
- **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-1266-2019

## Citation

> AI Analytics. FDA recall Z-1266-2019. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-1266-2019. Source: US FDA. Licensed CC0.

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