# FDA recall Z-0201-2019

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

## Product

GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.

## Reason for recall

GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners.    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.    UPDATE 5/27/2016:  Recall has been updated to include an additional product which includes the  Discovery 3.0T MR750 systems running Application Software DV24 R01, DV25 R02, or DV25.1 M3.

## 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-0201-2019
- **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-0201-2019

## Citation

> AI Analytics. FDA recall Z-0201-2019. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-0201-2019. Source: US FDA. Licensed CC0.

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