Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging…
Medical device recall Z-0693-2019. Published in FDA’s Enforcement Report on Jan 16, 2019.
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 Jan 16, 2019. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 51 states named
- 3,849 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?
Possible incorrect software version loaded.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Various GE Magnetic Resonance System on-site software version Product Usage: Magnetic resonance imaging equipment for general diagnostic use
3,849, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Product Name Sold Under System ID Model # *WH*MR SIGNA 1.0T HORIZON 5.X HISPE GPX23300 2108050 0.2T SIGNA PROFILE 2761614-1 5179427 0.7T OPENSPEED EXITE PC7479MR06 2377062-5 0.7T OPENSPEED EXITE PC3802MR02 2377062-5 1,5T HD ES/HS…
Every code shown here, 1,998 characters
Product Name Sold Under System ID Model # *WH*MR SIGNA 1.0T HORIZON 5.X HISPE GPX23300 2108050 0.2T SIGNA PROFILE 2761614-1 5179427 0.7T OPENSPEED EXITE PC7479MR06 2377062-5 0.7T OPENSPEED EXITE PC3802MR02 2377062-5 1,5T HD ES/HS 10079MRM74 5107849 1.0T SIGNA LX PH0095MR01 2214149 1.0T SIGNA LX PC0125MR02 2189500-3 1.5 ECHOSPEED HD 16-CH 0850270514 2226300 1.5 ECHOSPEED HD 4-CH 200-AP 409838HDCMR1 46-294231G1 1.5 ECHOSPEED HD 4-CH 200-AP 940220MR1 2214149-2 1.5 ECHOSPEED HD 8-CH 400-A 1344119 2226300 1.5 ECHOSPEED HD 8-CH 400-A 2624537EXCITE 5107849-2 1.5 ECHOSPEED HD 8-CH 400-AP 760323MR 2214149-2 1.5 ECHOSPEED HD 8-CH 400-AP 60001MRS01 5323286-101 1.5 HDE 8CH 3882691524MRCTR 5139394-2 1.5 HISPEED 3882635801MRSOR 2226300 1.5 HISPEED 4C 412099MR1 2226300 1.5 HISPEED HD 8-CH 400-AP 317338MR4 2214149-2 1.5 HISPEED HD 8-CH 400-AP 803936MRI 2214149-2 1.5 LX TO HDX 16C FORKLIFT UPG 614293MR7 2214149-2 1.5 SIGNA EXPLORER DZ1947MR01 5323286-101 1.5 SIGNA EXPLORER DZ1149MR02 5323286-101 1.5 T ECHOSPEED HD 4-CH 200-AP 35067MRS01 5107849-2 1.5 T ECHOSPEED MRI LY1006MR01 2189500-3 1.5 TWINSPEED HD 8CH-400-AP 910716BMR1 2377062-2 1.5T BRIVO MR355 AZ4010MR01 5341543 1.5T BRIVO MR355 AZ4027MR01 5341543 1.5T BRIVO MR355 AZ4004MR01 5323286 1.5T BRIVO MR355 AZ4015MR01 5341380 1.5T BRIVO MR355 082427010062 2214149-2 1.5T BRIVO MR355 082427210103 5341543 1.5T BRIVO MR355 082427210079 5341543 1.5T BRIVO MR355 082427200079 2214149-2 1.5T BRIVO MR355 082427310067 5341543 1.5T BRIVO MR355 082427040126 5341543 1.5T BRIVO MR355 082427110037 5341543 1.5T BRIVO MR355 082427190054 5323286 1.5T BRIVO MR355 082427190056 5341543 1.5T BRIVO MR355 082427270035 5341543 1.5T BRIVO MR355 082427190060 5341543 1.5T BRIVO MR355 082427190058 5341543 1.5T BRIVO MR355 082427230054 5341543 1.5T BRIVO MR355 082427230062 5341543 1.5T BRIVO MR355 082427220028 5341543 1.5T BRIVO MR355 082427220029 5341543 1.5T BRIVO MR355 082427220030 5341543 1.5T BRIVO MR355 082427220032 5341543 1.5T BRIVO MR355 082427170015…
FDA’s list runs to 169,967 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.
Worldwide Distribution - US Nationwide AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY Albania, Algeria, Argentina, Armenia, Australia, Austria, Azerbaijan, Bahrain, Bangladesh, Belgium, Bolivia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Ghana, Greece, Guadeloupe, Guatemala, Guyana, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Iraq, Italy, Jamaica, Japan, Kazakhstan, Kenya, Korea (Republic of), Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Malawi, Malaysia, Mauritania, Mauritius, Mexico, Moldova, Morocco, Nepal, Netherlands, New Caledonia, New Zealand, Nigeria, Oman, Pakistan, Palestine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, South Africa, Spain, Sri Lanka, Sudan, Sweden, Switzerland, Syria, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Uzbekistan, Venezuela, Viet Nam and Zambia
The states and territories these words name
51 states and territories.
Every one of them
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- District of Columbia
- Delaware
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Puerto Rico
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
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 Nov 15, 2018.
- FDA classified it on Jan 7, 2019.
- FDA’s Enforcement Report published it on Jan 16, 2019.
- FDA terminated it on Jan 17, 2021.
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 169,967 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
-
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.