SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE…
Medical device recall Z-1943-2013. Published in FDA’s Enforcement Report on Aug 21, 2013.
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 Aug 21, 2013. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 2 states named
- 7016 (2919 US; 4097 OUS) 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?
Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one customer site on the Signa HDxT 1.5T system, internal investigation revealed that the issue also impacts multiple GE healthcare MR Systems.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM GE SIGNA 3.0T WITH EXCITE MR SYSTEM GE SIGNA EXCITE 1.5T MR SYSTEM GE SIGNA EXCITE 3.0T MR SYSTEM Signa HDx Signa HDxt Signa HDi Signa Vibrant GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM (i.e. Signa Ovation 5 and Ovation HD) GE 1.5T SIGNA HDe MR SYSTEM GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (4) WITH EXCITE MR SYSTEM GE 0.7T SIGNA OPENSPEED (5) WITH EXCITE MR SYSTEM The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity System is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the Signa Infinity systems reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
7016 (2919 US; 4097 OUS), in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Ref. # 60808 “Products: Signa Infinity MR System with EXCITE Technology, Signa EXCITE 1.5T and Signa EXCITE 3.0T, Signa 3T with EXCITE, Signa 3T Infinity with EXCITE, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (Waukesha, WI) FMI 60808” Mfg Lot…
Every code shown here, 1,990 characters
Ref. # 60808 “Products: Signa Infinity MR System with EXCITE Technology, Signa EXCITE 1.5T and Signa EXCITE 3.0T, Signa 3T with EXCITE, Signa 3T Infinity with EXCITE, GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM (Waukesha, WI) FMI 60808” Mfg Lot or Serial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…
FDA’s list runs to 110,327 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: USA (nationwide) including DC and Puerto Rico and countries: ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIDJAN, BELARUS, BELGIUM, BOLIVIA, BOSNIA-HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, FINLAND, FRANCE, GEORGIA, GERMANY, GREAT BRITAIN, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAPAN,JORDAN, KAZAKHSTAN, KENYA, KUWAIT, LATVIA, LEBANON, LIBYA, LITHUANIAN, LUXEMBOURG, MALAYSIA, MALTA, MARTINIQUE, MEXICO, MOROCCO, NETHERLANDS, NEW ZEALAND, NORWAY, PAKISTAN, PANAMA, PARAGUAY, PERU. PHILIPPINES, POLAND, PORTUGAL, REPUBLIC OF MACEDONIA, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAK REPUBLIC, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TUR,EKY, UKRAINE, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, YUGOSLAVIA, MALAWI, MAURITANIA, NIGERIA, UKRAINE, IVORY COST, OMAN, ZAMBIA, UZBEKISTAN, ESTONIA, IRAQ, and JAMAICA.
The states and territories these words name
- District of Columbia
- Puerto Rico
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 21, 2011.
- FDA classified it on Aug 9, 2013.
- FDA’s Enforcement Report published it on Aug 21, 2013.
- FDA terminated it on Oct 22, 2014.
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: Visit.
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 110,327 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.