Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

GE Healthcare Recalled by GE Medical Systems, LLC Due to GE Healthcare has recently become aware of a...

Date: December 7, 2015
Company: GE Medical Systems, LLC
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact GE Medical Systems, LLC directly.

Affected Products

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

Quantity: 356 (98 US; 258 OUS)

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 25 states: AZ, CA, CO, DE, FL, IL, IN, ME, MD, MI, MN, MO, NH, NY, NC, OH, OK, OR, PA, SD, TN, TX, VA, WI, DC

Affected (25 states)Not affected

About GE Medical Systems, LLC

GE Medical Systems, LLC has 146 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report