# FDA recall Z-0553-2016

> **GE Medical Systems, LLC** · Class II · device recall initiated 2015-12-07.

## Product

GE Healthcare, 3.0T 6 Channel Phased Array  Flex Coil, M0050SS.    Product Usage The 3.0T GE 6-Channel Phased Array Flex Coil is indicated for use on the order of the physician in conjunction with a 3.0T MRI scanner, as an accessory to produce 2D and 3D images.

## Reason for recall

Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient thermal injury. There have been no injuries reported as a result of this issue.

## Distribution

Worldwide Distribution- US Distribution including the states of AZ, CA, CO, IL IN, MI, MN, NY, OH, OK, SD, TX, WI, VA, DE, FL, MD, ME, MO, NC, NH, OR, PA, TN, WI, DC, PR  and the countries of CANADA, CHINA, CZECH REPUBLIC, ITALY, JAPAN, NETHERLANDS, NEW ZEALAND, PORTUGAL, ROMANIA, SOUTH AFRICA, SWITZERLAND, TURKEY, SWEDEN, AUSTRALIA, BRAZIL, CZECH REPUBLIC, EGYPT, FRANCE, GERMANY, ITALY, MEXICO, RUSSIA, SAUDI ARABIA, TAIWAN, UNITED KINGDOM,  INDONESIA, ESTONIA, REPUBLIC OF KOREA,  POLAND, KUWAIT, SPAIN.

## Key facts

- **Recall number:** Z-0553-2016
- **Recalling firm:** GE Medical Systems, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2015-12-07
- **Report date:** 2018-10-31
- **Termination date:** 2018-11-08

- **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-0553-2016

## Citation

> AI Analytics. FDA recall Z-0553-2016. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/Z-0553-2016. Source: US FDA. Licensed CC0.

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