GE Healthcare, SIGNA Excite 3.0T
Medical device recall Z-0256-2016. 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
- 55 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 Excite 3.0T. MR System for use as a diagnostic imaging device.
55, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
00000304469MR0 910609CF3T 00000000043586 336713WFUMR 002004-0924-11 321MR3T3 2333 901726OPMR 002004-0520-05 727785MR 00000005232YR4 414649MR5 000000HDMR2722 858657MR1 1556044 9085223T 002004-0520-06 407999MR3T 002004-0805-01 8109873T…
Every code shown here, 1,374 characters
00000304469MR0 910609CF3T 00000000043586 336713WFUMR 002004-0924-11 321MR3T3 2333 901726OPMR 002004-0520-05 727785MR 00000005232YR4 414649MR5 000000HDMR2722 858657MR1 1556044 9085223T 002004-0520-06 407999MR3T 002004-0805-01 8109873T 00000263655MR3 321MR3T2 00000006583YR9 HSS3T5 002005-0216-15 731425MR2 002005-0216-19 6053883T 002005-1020-30 248465MR3T 002005-0127-12 248849MR3T 002004-1117-11 916UCDMR3T 000000HDMR3737 2059393T 002005-0331-11 919684MR6 000000HDMR3654 402219MR3T 002005-0519-19 205345MR3T 000000000R3780 210921SWGMR 002005-1201-36 662MSU3T 000000HDMR5675 407303MR3T 00000267527MR0 903870VM3TMR1 000000HDMR5786 602285MR4 00000HDMR10672 ASLWEST30MR 00000269041MR0 0910272044 00000266160MR1 2550000 00000257756MR7 082427230015 00000279423MR8 082427310015 00000280319MR5 082427160051 00000280898MR8 082427100075 00000282686MR5 082427010032 00000283076MR8 082427300008 00000283386MR1 082427070048 00000265969MR6 082427040042 00000279752MR0 082427160050 00000273833MR4 M4434864 00000264643MR8 M4135138 00000838BD4EC9 A5103135 00000273267MR5 YM1408 00000267200MR4 YM1396 00000267203MR8 YM1397 00000268417MR3 YM1414 00000269575MR7 YM1403 00000270026MR8 YM1405 00000272070MR4 YM1407 00000272969MR7 YM1406 00000260692MR9 0850270170 000000HDMR3167 81MR3T2715363 00000013212GQ6 7771MREXCITE3 00000254375MR9 NPV26104 00000266826MR7 0853270071 00000269581MR5 0853270072
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.”
- 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.