Food, drugs, devices › GE Medical Systems, LLC
Device recall: GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2.
FDA enforcement event 72892 is a device recall by GE Medical Systems, LLC of Waukesha, WI, initiated 7 Dec 2015 and classified Class II, with 2 product records.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,153 device enforcement events initiated in 2015 carry the same class.
Status: Terminated, terminated 8 Nov 2018. Initiation: voluntary: firm initiated. GE Medical Systems, LLC has 42 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
GE Medical Systems, LLC, Waukesha, WI.
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,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0201-2019 | GE Healthcare, Discovery 3.0T MR750, 5148810-2, 5373011-2, 5499460-2. | 356 (98 US; 258 OUS) | Class II | Terminated | 31 Oct 2018 |
| Z-0553-2016 | 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. | 90 (54 US; 36 OUS) | Class II | Terminated | 31 Oct 2018 |
Context
Other enforcement events for GE Medical Systems, LLC
All 42 events for GE Medical Systems, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "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,…"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 8 Nov 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.