GE Healthcare, SIGNA HDxt 3.0T
Medical device recall Z-0259-2016. Published in FDA’s Enforcement Report on Nov 18, 2015.
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 Nov 18, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 215 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?
When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling suggests the actual SAR in the head could exceed IEC60601-2-33 limit of 3.2 W/kg for some scans.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, SIGNA HDxt 3.0T. Product Usage: The 1.5T Signa HDx family and 3.0T Signa HDx family are a whole body magnetic resonance scanner for use as a diagnostic imaging device.
215, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00000275183MR1 609652MR3T 00000848BD5339 2145903TXMRE5 000000HDMR3480 MR98508 000000HDMR5861 865545MR3T 002004-0513-07 617754MR4 002004-0701-18 3137453TMR 000000HDMR2370 NYP347652 002004-0701-15 713704HMR4 000000HDMR3070 517353VH3…
Every code shown here, 1,997 characters
00000275183MR1 609652MR3T 00000848BD5339 2145903TXMRE5 000000HDMR3480 MR98508 000000HDMR5861 865545MR3T 002004-0513-07 617754MR4 002004-0701-18 3137453TMR 000000HDMR2370 NYP347652 002004-0701-15 713704HMR4 000000HDMR3070 517353VH3 00000HDMR20151 313294MR 002004-0917-18 617754MR5 002004-0930-12 615TANMR 002005-0114-20 614722MR3 002005-0127-08 513451MR2 000000000R4044 661CBCCMR 000000HDMR4161 203863MR3T 000000HDMR3916 313593MR3T 002005-0328-17 2709263HD 00000HDMR20114 419383MR3T 000000HDMR2328 7067213TMR 00000930BD5D54 801588MR2 002004-0520-04 615777MR3T 000000HDMR1169 LONGWOOD30MR2 000000HDMR3396 3096653TMR 000000HDMR2818 402552NMC2 000000HDMR2952 415600D3T 00000266754MR1 423844MR2 000000HDMR2721 212305MR83T 000000HDMR3624 RADNETMR1521 00000011015YR5 928317MR1 000000HDMR2854 619543MR2 000000HDMR2481 703478MR5 0948BD61FA 509758TMR 00000275288MR9 831423MR 000000HDMR5864 480425MR5 00000274078MR5 510MIA3T 0000006-0425-3 610433MR 002005-1212-15 602406MR6 00000274744MR2 M48823 00000274745MR9 573815BMR1 000000HDMR5241 406751K3T 00000279999MR7 703573MR5 00000281442MR4 928213MR3T 00000282733MR5 504MCLMR 00000284262MR3 865481MR3T 00000284235MR9 612626MR3T #N/A 269342MR3TCH2 00000285497MR4 517374MR3T 002004-0416-18 415353UMR9 002005-0316-09 850656TD3T 00000282373MR0 408GS3TMR 000000HDMR5569 5853413T 00000300458MR7 RADNETMR594 00000287256MR2 305674MR1 000000HDMR6028 865218MR3T 000000HDMR4230 6109883TMR 00000276721MR8 407BDIMR 00000290478MR7 3017233TMR 00002982315MR9 ALLIANCESIG468 00000939BD5F59 310623MR 00000280229MR6 INSIGHTMR3233 00000296233MR0 515282MR1 00000280671MR9 RADNETMR1583 000000HDMR6392 602588CMR1 00000297726MR2 RADNETMR1589 N/A 407SMWPMR1 00001011BD6684 480464MR1 00000298718MR8 RADNETMR1595 0002005-1109-6 225763MR 00000299962MR1 RADNETMR590 00000300457MR9 RADNETMR1597 00000300769MR7 RADNETMR592 00000298773MR3 213387MR 35A14718B 626359MR3 000000HDMR3359 213777MR 00000265629MR6 405CDIMR 000000HDMR2303 269342MR3T2 00000283743MR3 808AMIMR 00000848BD531F RADNETMR612…
FDA’s list runs to 5,442 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 including DC, PR and GU and the countries of ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BERMUDA, BOSNIA HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHINA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GERMANY, GREECE, HONG Kong, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, KAZAKHSTAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NEW ZEALAND, NORWAY, PERU, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, and VENEZUELA.
The states and territories these words name
- District of Columbia
- Guam
- 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 Aug 31, 2015.
- FDA classified it on Nov 9, 2015.
- FDA’s Enforcement Report published it on Nov 18, 2015.
- FDA terminated it on Sep 7, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, 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 5,442 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.