GE Healthcare, Signa Infinity MR System
Medical device recall Z-2339-2015. Published in FDA’s Enforcement Report on Aug 12, 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 Aug 12, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 82 (39 USA; 43 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?
A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped left-right with incorrect orientation annotation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
GE Healthcare, Signa Infinity MR System; Signa MR/i MR System; SmartSpeed; EchoSpeed Plus; HighSpeed Plus, Signa Infinity MR System with EXCITE Technology, Excite II, Signa 3T Infinity with Excite, Signa Excite 1.5T and Signa Excite 3T, Signa Excite HD, Signa HD 1.5T and Signa HD 3.0T, Signa HDx, Signa HDxt, Signa HDi. Whole body magnetic resonance diagnostic imaging scanners.
82 (39 USA; 43 OUS), 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 00000153282MR9 501362MR1 00000165901MR0 ZA2101MR02 00000213818MR8 37190MRI 00000213341MR1 M27590 00000247386MR6 707459MR2 00000231538MR0 706583MR 00000236418MR0 850862FTS1CH1 00000242668MR2 502868MR…
Every code shown here, 1,995 characters
Mfg Lot or Serial # System ID 00000153282MR9 501362MR1 00000165901MR0 ZA2101MR02 00000213818MR8 37190MRI 00000213341MR1 M27590 00000247386MR6 707459MR2 00000231538MR0 706583MR 00000236418MR0 850862FTS1CH1 00000242668MR2 502868MR 00000267704MR5 314525SAMR2 00000227724MR2 ALLIANCESIG262 00000214667MR8 853270051 00000242173MR3 ALLIANCESIG287 00000241518MR0 502633MR1 00000231910MR1 212956MR2 00000237000MR5 0910272037 00000241867MR1 HU1008MR01 00000243769MR7 920279006 00000047514WH5 YM0774 00000285490MR9 954916MR1 00000284687MR1 309655MRI1A 00000280860MR8 1202470 00000282692MR3 902496MRI3 00000282813MR5 0835270010 00000278669MR7 508755MR1 00000267211MR1 0850270458 000000HDMR3141 SHIMR598 000000HDMR5777 919470MR2 000000HDMR3905 709737MRI 000000HDMR2541 M4018076 000000HDMR5379 M4135138 00000HDMR10710 10543MRM01 00000301019MR6 SMSDML2 00000292334MR0 INSIGHTMR1915 00000290735MR0 704323MR1 00000300812MR5 MR14604YR3 00000297420MR2 082427080028 00000239401MR3 404352PNC 00000209414MR2 732591MR 00000206394MR9 516365MR 00000224271MR7 RADNETMR1515 00000190316MR0 1167491 00000223494MR6 1299290 00000223256MR9 84631 00000227239MR1 2817688 00000230273MR5 2817679 00000240274MR1 083027002100393 00000199094MR4 YM0620 00000237547MR5 600101MR01 00000210080MR8 941262MR 00000214332MR9 208367LX5 00000204255MR4 770438EAMR 00000218279MR8 2214SIGNA15 00000215878MR0 0853270047 00000193672MR3 AE1011MR01 00000001634M25 MRR8049 00000005464M23 082427070113 00000000108M21 2807539 00000267104MR8 864225MR 00000254183MR7 304347MR1 00000264011MR8 EG1522MR01 00000006705YR8 901226MR1 00000007870YR9 2651831 00000009552YR1 FI1012MR04 00000009010YR0 FI1012MR03 00000006662YR1 0850270197 002003-0922-09 ALLIANCESIG293 0002005-0725-4 5360MREXCITE3 00000279502MR9 304766TMR 00000284315MR9 208265BMR 00000285664MR9 904399MR2 00000280274MR2 561798MR1 00000286778MR6 2718385 00000276273MR0 4716MREXCITE 00000299465MR5 EG1279MR01 00000309342MR4 082427010077 00000264527MR3 SMSFFI2 00000263933MR4 A5156029 00000266764MR0…
FDA’s list runs to 2,083 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) and Internationally to UNITED ARAB EMIRATES, ARGENTINA, BRAZIL, INDIA, EGYPT, CHINA, FINLAND, FRANCE, UNITED KINGDOM, HUNGARY, JAPAN, INDONESIA, KOREA, MEXICO, NEW ZEALAND, CANADA, AUSTRALIA, ITALY, RUSSIAN FEDERATION, TAIWAN, and SOUTH AFRICA.
These words name no state.
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 Jul 10, 2015.
- FDA classified it on Aug 5, 2015.
- FDA’s Enforcement Report published it on Aug 12, 2015.
- FDA terminated it on Nov 19, 2015.
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 2,083 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.