# FDA recall Z-3029-2017

> **GE Medical Systems, LLC** · Class II · device recall initiated 2017-05-11.

## Product

Signa PET/MR (K163619, K142098)    Product Usage:  The SIGNA PET/MR system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and/or PET imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders. The MR is intended to produce transverse, sagittal, coronal and oblique cross-sectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as descr

## Reason for recall

Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.

## Distribution

US Nationwide in the states of :  AK, CA, CO, CT, DE, FL, IA, IL, IN, KS, KY, LA, MD, MO, ND, NE, NJ, NY, OH, PA, TX, WA, and WI

## Key facts

- **Recall number:** Z-3029-2017
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-05-11
- **Report date:** 2017-08-23
- **Termination date:** 2020-09-09

- **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-3029-2017

## Citation

> AI Analytics. FDA recall Z-3029-2017. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-3029-2017. Source: US FDA. Licensed CC0.

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