Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
Medical device recall Z-1928-2016. Published in FDA’s Enforcement Report on Jun 15, 2016.
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 Jun 15, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- 25 states named in where it went
- 101 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?
The gas venting may not occur properly. A site reported a magnet quenching with subsequent venting of the cryogen gas into the magnet room. Cryogen gas that vents into the magnet room could cause critical deprivation of oxygen to users and patients.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Optima 1.5T MR430s MR Scanner, a diagnostic imaging device
101, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
0001272012-001 615VEMR 0003062012-008 605328SMR15 0012102012-001 SMRDEMO01 0005162012-003 801243MR2 SM05132013-001 970879MR430 SM10172011-004 509482MR3 SM06142013-001 641428ONI SM10302012-006 ARIA430S SM06272013-006 207OA430MR…
Every code shown here, 1,988 characters
0001272012-001 615VEMR 0003062012-008 605328SMR15 0012102012-001 SMRDEMO01 0005162012-003 801243MR2 SM05132013-001 970879MR430 SM10172011-004 509482MR3 SM06142013-001 641428ONI SM10302012-006 ARIA430S SM06272013-006 207OA430MR SM11262012-007 USOTCSMR SM07082013-012 719766SMR 0SM5312013-001 760725MR1 SM08152013-002 703805ONIMR4 SM11252013-001 310665MR 0000SM09202013 208557MR2 SM05212013-004 VAD430 SM11132012-002 856581MR430 SM12172012-001 303577MR2 0001212012-001 786308MR1 0012222011-001 973586MR 0006012011-001 SINAI601 0007132011-001 516482MR430 0012042011-001 MKMG430S 0 02162012-001 805679ONI 0012142011-001 215DOY430S 0006112012-004 360786ONIMR 0003062012-007 212288ONI 0010272011-009 513636NICMR 0003282012-001 518453MR2 0002112012-001 803434ONI Missing_SN_GON4194272 402EXTMR SM03132014-002 H430SMR SM05142014-006 520VAONIMR SM07182014-009 352376ONI1 SM11062012-001 MRSM11062012001 0002022012-001 0910272081 0004212012-001 514697ONI SM01232014-003 SM01232014-003 SM05192014-003 MRSM05192014003 0005252012-002 MRMEDSMR3 SM02252014-003 082427010079 SM03292014-007 082427020055 SM05272014-007 082427020060 SM09202013-017 082427040145 0SM0225013-004 082427030080 SM06202013-002 MRSM06182013002 SM01202014-014 DK1000MR04 SM10242013-002 DK1075MR01 0000DK1030MR03 DK1030MR03 0012132011-001 DK1068MR01 0001192012-001 FI1378MR01 0011052011-002 FI1006MR02 SM01102014-001 M24070304 SM01152013-001 L1650217 SM03052014-004 M176430610 SM04152014-001 M5817305 SM04292014-002 M2862820 SM07182014-014 M172471308 SM08152013-003 M4215583 SM12192013-003 M219000205 SM02042014-003 D4185525 SM07182014-008 0828270040 0002042012-001 IS1019MR01 SM10122012-003 A5177233 SM12102012-003 A287971801 0007172011-001 A127292410 0009242011-001 A5725513 SM02132014-001 OM0005 SM03202014-001 OM0004 SM11122013-007 OM0003 SM12202013-001 OM0100 0005102012-004 OM0001 0008022012-003 OM0002 0007302012-008 0850270400 SM07182014-012 KW1019MR04 SM07182014-013 KW1001MR05 0005152012-004 DRD0120 SM07142014-003 GRN0121…
FDA’s list runs to 2,565 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.
US: AL, AZ, CA, CO, FL, ID, IL, IA,ME, NE, NV,NH, NJ, NY, NC, OH, PA, SC, SD, TN, TX, UT,VA, WA, WI. OUS: Argentina Australia Austria Brazil Canada Chile Colombia Denmark Egypt Finland France Germany Greece Hong Kong Iceland Italy Japan Korea (Republic of) Kuwait Malaysia Netherlands Norway Peru Poland Portugal Russia Singapore South Africa Spain Sweden Switzerland Ukraine United Arab Emirates United Kingdom
The states and territories these words name
25 states and territories.
Every one of them
- Alabama
- Arizona
- California
- Colorado
- Florida
- Iowa
- Idaho
- Illinois
- Maine
- North Carolina
- Nebraska
- New Hampshire
- New Jersey
- Nevada
- New York
- Ohio
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- Wisconsin
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 May 9, 2016.
- FDA classified it on Jun 8, 2016.
- FDA’s Enforcement Report published it on Jun 15, 2016.
- FDA terminated it on Jul 11, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- GE Healthcare, LLC, 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 2,565 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.