This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450,…
Medical device recall Z-1035-2015. Published in FDA’s Enforcement Report on Feb 25, 2015.
- FDA Class I
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 Feb 25, 2015. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 3 states named
- 12,968 (5,708 US, 7,260 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 I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threatening injuries. The MRU must be connected to the magnet at all times.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
This correction applies to all GE Healthcare MRI systems with superconducting magnets: Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, GE 1.5T Signa HDe, Optima MR360, Brivo MR355, Signa Excite-HD 1.5T & 3T, Signa Excite 1.5T HD Twinspeed, Signa Excite 1.5T HD Echospeed, Signa Excite 1.5T HD Highspeed, 1.5T Signa Infinity TwinSpeed , 1.5T Signa Infinity EchoSpeed Plus, 1.5T Signa Infinity HiSpeed Plus, 1.0T Signa Infinity HiSpeed Plus. 1.0T Signa Infinity SmartSpeed, Signa EXCITE 3.0T, Signa EXCITE 3.0T HD, Signa Excite 1.5T TwinSpeed, Signa Excite 1.5T EchoSpeed, Signa Excite 1.5T HiSpeed, Signa Excite 1.5T SmartSpeed, Signa Excite 1.5T, Signa Excite 3.0T, Signa Contour/I, Signa OpenSpeed, Vectra, MR Max, Optima MR450w GEM, Discovery MR750W GEM, Optima MR450w. Product Usage: Magnetic resonance (MR) diagnostic devices are intended for producing images of the internal structures of the body based on the spatial distribution of molecules exhibiting magnetic resonance. Most MR systems are intended for diagnostic use.
12,968 (5,708 US, 7,260 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 00000678440YM9 11 00000439289YM0 8 00000440422YM4 12 00000159739MR2 10 00000340776HM4 MRR9350 00000300911HM5 MRR8614XXX 00000307145MR3 MR307145MR3XXX 00000347253HM7 MRR9546XXX 00000014401YR4 2867718MRHDEXXX…
Every code shown here, 1,998 characters
Mfg Lot or Serial # System ID 00000678440YM9 11 00000439289YM0 8 00000440422YM4 12 00000159739MR2 10 00000340776HM4 MRR9350 00000300911HM5 MRR8614XXX 00000307145MR3 MR307145MR3XXX 00000347253HM7 MRR9546XXX 00000014401YR4 2867718MRHDEXXX 00000227450MR7 333MR3TXXX 00000286146MR6 813EXCITEHDXXX 00000005670GQ5 33575MRI 00000015190GQ2 813EXCITEHD 000000000R5168 PPR88300 00000263679HM3 MEX68913 104203 GPX23300 00000117703YM9 MP917500 00000275290MR5 M2322231 00000144994MR1 F4168003 00000142868MR9 M9886807 00000208223MR8 M4488929 00000834BD4B76 M2865810 00000015769GQ3 M200598201 00000287360MR2 IL1028MR04 00000269936MR1 110010MR03 00000010081GQ8 M4497252 00000265724MR5 80040MRS02 00000213821MR2 00568MRS02 00000274388MR8 M4160077 00000439293YM2 850270280 00000439303YM9 850270057 00000439318YM7 850270174 00000439320YM3 850270022 00000439325YM2 850270186 00000279611MR8 10079MRM74 00000000905M20 PL2130MR01 00000165934MR1 850270060 000000000R6047 55MR2726459 00000284297MR9 83027062101067 00000264745MR1 83027602200145 00000265178MR4 83027202100215 00000270025MR0 83027242101006 00000273677MR5 83027862100276 00000274832MR5 83027202100306 00000286281MR1 83027602101557 00000276493MR4 BA4073MR01 8.70972E+21 706774MRI 412648MR1 412784MR1 317630HDMR 610902HD1 MSK55MR1 317630MR1 LONGWOOD15MR 330535MR2 859226MR 208367LX12 00000014890G08 910272052 00000264618MR0 M4016036 00000015059GQ9 SA1014MR02 00000264740MR2 AZ1003MR01 00000262798MR2 KW1013MR02 00000274935MR6 SY2037MR01 352344MR ALLIANCESIG437 409838HDCMR1 INSIGHTMR2025 954587MR1 210590NEHDMR 940220MR1 00000015200GQ9 SD1063MR01 00000276248MR2 27003MRS01 00000013471GQ8 856270037 00000013391GQ8 24527633818MRI 00000290734MR3 2771768 00000014972GQ4 A5395304 00000282503MR2 LV4038MR01 00000267807MR6 DZ1057MR01 00000273006MR7 2624537EXCITE 00000014505GQ2 IR1288MR02 00000013604GQ4 KW1018MR01 00000272427MR6 SI4024MR01 00000276153MR4 3882676145MRMET 00000280627MR1 3882676151MRCTR AM11ZVXTLW7 210351HDMR 708747OFMR 412641MR2 360487MR2 8.70972E+13…
FDA’s list runs to 255,025 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 in all states in continental USA including DC, PR, GU, and the countries of ALBANIA, ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELARUS, BELGIUM, BOLIVIA, BOSNIA & HERZEGOVINA, BRAZIL, BULGARIA, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR,K ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, GUATEMALA, GUYANA, HONDURAS, HONG KONG, HUNGARY, ICELAND, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, REPUBLIC OF KOREA, KUWAIT, LATVIA, LEBANON, LIBYAN ARAB JAMAHIRIYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALTA, MARTINIQUE, MAURITIUS, MEXICO, MOROCCO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NICARAGUA, NIGERIA, NORWAY, OMAN, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REUNION, ROMANIA, RUSSIA, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TUNISIA, TURKEY, UKRAINE , UNITED ARAB EMIRATES, UNITED KINGDOM, URUGUAY, UZBEKISTAN, VENEZUELA, VIETNAM, ZAMBIA.
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 Jan 7, 2015.
- FDA classified it on Feb 18, 2015.
- FDA’s Enforcement Report published it on Feb 25, 2015.
- FDA terminated it on Sep 10, 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 255,025 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.