GE Healthcare SIGNA Creator, SIGNA Explorer
Medical device recall Z-2731-2016. Published in FDA’s Enforcement Report on Sep 14, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Sep 14, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 12 states named in where it went
- 383 (US = 24;OUS = 359) how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patient and higher than expected localized heating. There have been no failures of this type reported, and no injuries reported as a result of this issue.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare SIGNA Creator, SIGNA Explorer. Diagnostic Imaging Device.
383 (US = 24;OUS = 359), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Mfg Lot or Serial # System ID MNEXP1600002MR 480425MR7 001709TA5 520ASRMR 003175TA7 916RAFMR 002448TA9 559449SPMR 002674TA0 559449SPMR 002027TA1 203337MREXP 003012TA2 GON: 4371049 002974TA4 239458MR1 003399TA3 239292MR1 002380TA4 305983MR3…
Every code shown here, 1,995 characters
Mfg Lot or Serial # System ID MNEXP1600002MR 480425MR7 001709TA5 520ASRMR 003175TA7 916RAFMR 002448TA9 559449SPMR 002674TA0 559449SPMR 002027TA1 203337MREXP 003012TA2 GON: 4371049 002974TA4 239458MR1 003399TA3 239292MR1 002380TA4 305983MR3 002753TA2 727869MR 003356TA3 954473MR1 003176TA5 773843SCMR 000753TA4 574206MR 003013TA0 508746JMR2 003019TA7 417269MRS2 003371TA2 601853MR1 001027TA2 704384MINT 001059TA5 7 04384MINT 002453TA9 513569MR1 002741TA7 513584MR 001063TA7 254965CTOMR1 002879TA5 920560EXP 002831TA6 GON: 1532602 002023TA0 DZ1035MR03 002081TA8 DZ1863MR01 003302TA7 GON: 4399202 002742TA5 GON: 4374136 003076TA7 DZ1149MR02 003731TA7 DZ2014MR01 003079TA1 DZ1908MR01 003078TA3 DZ1174MR01 003565TA9 GON: 4345190 003134TA4 DZ1947MR01 002883TA7 83147183761 003174TA0 83140192745 003508TA9 83151589682 003403TA3 083027600486516 001232TA8 190073MR02 003439TA7 2626380 003441TA3 MRR10842 002687TA2 MRR10744 003440TA5 MRR10833 002090TA9 MRR10671 003793TA7 GON: 4393875 002949TA6 604988MRI 002219TA4 MRR10679 003212TA8 MRR10843 002876TA1 MRR10762 003177TA3 MRR10799 003754TA9 MRR10892 003359TA7 MRR5954 002885TA2 EG1826MR02 002450TA5 EG1990MR01 002886TA0 EG2266MR01 001502TA4 EG1112MR02 003213TA6 EG1709MR01 003083TA3 EG1522MR01 003133TA6 EG1237MR01 003354TA8 EG1505MR02 002446TA3 EG1196MR01 002940TA5 EG1998MR01 002743TA3 EG1245MR03 003267TA2 EG1069MR02 003172TA4 GP1022MR02 001405TA0 X227040904 001124TA7 A1039630 001231TA0 X2881410 000898TA7 M4174549 001307TA8 M23084330 003307TA6 M1265006 003511TA3 M1265008 001029TA8 X102860306 001171TA8 M185296206 001169TA2 X756087020 003265TA6 M2569125 000973TA8 M8321415 001028TA0 X116370509 001503TA2 M2269855 001233TA6 M2533228 001170TA0 M2748222 001936TA4 M2322255 001238TA5 M8317617 001938TA0 M215631205 000331TA9 M386271501 001123TA9 M2718163 001237TA7 X751964008 000965TA4 M203097404 002022TA2 M4213545 001251TA8 M2316318 001026TA4 RE1017MR01 002975TA1 X868131014 003725TA9 A1039633 003604TA6 M2485629 003783TA8 L2202007 003266TA4 GP1052MR03…
FDA’s list runs to 7,919 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
US: AZ, CA, CT, FL, IL, MA, MS, MO, NC, PR, TX, WI. OUS: Algeria, Australia, Bangladesh, Belgium, Brazil, Canada, Colombia, Dominican republic, Egypt, France, Germany, Ghana, Guatemala, HONG KONG, Hungary, India, Indonesia, Iran, Italy, Jamaica, Japan, Korea, Kuwait, LEBANON, Lithuania, Maldives, Martinique, Mexico, MOROCCO, Netherlands, New Zealand, OMAN, Pakistan, Philippines, Poland, Portugal, Romania, SAUDI ARABIA, Singapore, South Africa, Spain,Sweden, Tanzania, Thailand, Turkey, United Arab Emirates, United Kingdom, Vietnam.
The states and territories these words name
- Arizona
- California
- Connecticut
- Florida
- Illinois
- Massachusetts
- Missouri
- Mississippi
- North Carolina
- Puerto Rico
- Texas
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Aug 31, 2016.
- FDA classified it on Sep 2, 2016.
- FDA’s Enforcement Report published it on Sep 14, 2016.
- FDA terminated it on Jul 31, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, of Waukesha, WI.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 7,919 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.