GE Healthcare, SIGNA HDx 3.0T
Medical device recall Z-0258-2016. 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
- 350 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 HDx 3.0T. Product Usage: The GE Signa HDx MR system is a whole body magnetic resonance scanner for use as a diagnostic imaging device.
350, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
002003-0922-04 713441MR5 1583678 732632MR3 002003-1015-09 713441MR7 00001009BD6576 713792AMR12 000000HDMR5656 417269MRS1 00000HDMR10766 623433MR1 00000265552MR0 9525413TMR 00000026005MR8 503215MR1 002004-1102-17 7705353TMR 00000265805MR2…
Every code shown here, 1,992 characters
002003-0922-04 713441MR5 1583678 732632MR3 002003-1015-09 713441MR7 00001009BD6576 713792AMR12 000000HDMR5656 417269MRS1 00000HDMR10766 623433MR1 00000265552MR0 9525413TMR 00000026005MR8 503215MR1 002004-1102-17 7705353TMR 00000265805MR2 ACB41121MR HDMR5274 CBICMR1 0002005-0606-3 615284MR3T 000000HDMR5581 503216MR3 000000HDMR2301 269342MR3T 000000HDMR3234 303340MR 00000273869MR8 214345SWD3TMR1 000000HDMR2559 805GI3T HDMR2980 732223MR 00000275049MR5 706UGA3T 00000275649MR2 719595MR 00000275647MR6 3173383T1 #N/A 919684MR3 00000276435MR5 901226MR1 1002BD63EF 719542MR 00000275050MR3 631427MR3T 00000276722MR6 5857853T #N/A 5857853TTIP 00000273253MR5 717975MR3 00000007498YR9 212288GE3T 00000275967MR8 850916A3T 00000275648MR4 908725MR 00000278851MR1 425297RMR 00000006726YR4 COR373216 HM3652 715839MR3T 00000007556YR4 210617TCAMR2 00000HDMR10718 773665MR3T 00000278679MR6 708383WS3T 00000279918MR7 515643MR3T 00000279614MR2 904996MR3T 00000271119MR0 513556MR 00000280000MR1 630CDH3T 00000278678MR8 916KM3TMR 00000279613MR4 516562MR3T 00000279068MR1 805569MR 00000281154MR5 COR373219 00000282007MR4 4047783TMR 00000280949MR9 720848MR2 00000281342MR6 404772NMR3T 00000275646MR8 901572L3T 00000282796MR2 6622343TMR 00000280948MR1 650FALK3TMR 00000282731MR9 509474SH3T 00000280947MR3 2063203TMR 00000280670MR1 813251MR3T 00000276718MR4 MR129033 00000028261MR4 214433TN3TMR 00000282371MR4 7654493T 00000275650MR0 731935MR3 000000HDMR5671 323442MR3 000000HDMR3333 801IMCMR3 00000287415MR4 BEV3TMR 00000283027MR1 808591MR 00000283776MR3 480354MR1 00000284263MR1 2489643T 00000280231MR2 301496MR3T6MR 000000HDMR2685 301496MR3T5MR 00000285055MR0 850475IC3T 00000284234MR2 6053283TMR 00000286088MR0 540776MR3 00000283408MR3 CONCORD3T 00000286447MR8 217544MR1 00000280436MR7 8047643T 00000284576MR6 602406R3T 00000284575MR8 212639GE3T 000000HDMR1159 2187493T 00000282795MR4 480324MR1 00000286433MR8 828213MR 00000286478MR3 309655MRI3T 00000286744MR8 847SAMC3T 00000287255MR4 504447MR3 00000287417MR0…
FDA’s list runs to 8,736 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 8,736 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.