GE Healthcare, SIGNA HD 3.0T
Medical device recall Z-0257-2016. 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
- 97 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 HD 3.0T. Product Usage: The Signa Profile EXCITE MR system is an open, whole body scanner for use as a diagnostic imaging device. It may be utilized for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR safe biopsy needles.
97, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
002005-1018-15 352333MR3T 000006-0523-13 716859MR3T 00001003BD6425 352376MR3T2 00000280001MR9 MR129031 00000285499MR0 2154563TMR 000000HDMR3702 RADNETMR554 00000274930MR7 805CHLIMR1 00000280057MR1 513558MR3T 00000274998MR4 213977MR2…
Every code shown here, 1,991 characters
002005-1018-15 352333MR3T 000006-0523-13 716859MR3T 00001003BD6425 352376MR3T2 00000280001MR9 MR129031 00000285499MR0 2154563TMR 000000HDMR3702 RADNETMR554 00000274930MR7 805CHLIMR1 00000280057MR1 513558MR3T 00000274998MR4 213977MR2 002004-0713-06 ACB41109MR 002004-0406-08 323442MR2 002004-0406-15 323442MR1 00000273396MR2 7326133T 002004-1115-19 865373MR1 002005-0316-05 7576713T 0002005-0606-4 205750MR2 00000274839MR0 9287573TMR 002006-0119-15 559325CIIMR1 0002005-1201-3 256734MR3T 002005-1003-15 201487MR 000000HDMR2996 6053223TMR 000000HDMR3245 775RDC3T 002005-0620-16 405634S3T 00000269460MR2 602406IMR 00000275670MR8 813972VAMR 0002005-1121-7 480614MR1 00000273230MR3 602689MR1 002005-1201-20 601288MR3T 00000275936MR3 ALLIANCESIG463 00000275086MR7 650306SMR3T 00000275162MR6 772VRAMR3T 00000273459MR8 360397MR2 0002005-0104-5 662841MR4 000006-0511-20 336852SEMR 00000278626MR7 228KAFBMR3T 00000278619MR2 806212MR3T 00000278722MR4 337261MR1 00000281703MR9 916DR3TMR 0002005-0511-5 203797MR3T 002005-1115-04 615342MR3T 00000282868MR9 504873TMR3 00000281682MR5 859275MR3T 000000HDMR5653 RADNETMR608 00000000036657 480584MR1 #N/A TRAINING789 N/A 201669MR2 00000278623MR4 972378NSC3TMR1 00000267322MR6 920568MR3T 00000273365MR7 503280MR2 0002005-1201-6 865541MR3T 00000086257DP3 901516U3T 00000264748MR5 0910277003 00000268123MR7 0910272046 AZ1003MR02 00000282790MR5 082427090245 00000285380MR2 082427100084 00000286559MR0 082427090090 00000286800MR8 082427100089 00000287879MR1 082427040076 00000288667MR9 082427070050 00000289798MR1 082427100093 00000261198MR6 082427210039 00000262803MR0 082427070034 00000262931MR9 082427040047 00000265593MR4 082427160041 00000266147MR8 082427040061 00000267973MR6 082427040052 00000270974MR9 082427100064 00000271233MR9 082427040046 00000272894MR7 082427140039 00000273229MR5 082427120044 00000277189MR7 082427160049 290392MR0¿¿¿¿¿¿¿¿¿¿ 082427270017 00000265589MR2 DK1083MR04 00000000WB0692 ET1009MR01 00000262460MR9 0828270021IB01 00000270245MR4…
FDA’s list runs to 2,524 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 2,524 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.