MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
Medical device recall Z-1927-2016. 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
- 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?
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?
MSK 1.5T Extreme MR Scanner, a diagnostic imaging device
97, 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 0001072011-001 708216MR3 0001082010-001 AIC202 0001272010-001 RADNETMR1656 0002032011-001 407333EXTMR 0003072010-001 702254LVRMR 0003242009-001 JCI178 0004012010-001 201487ONI 0005152009-001 ZPR2185…
Every code shown here, 1,992 characters
Mfg Lot or Serial # System ID 0001072011-001 708216MR3 0001082010-001 AIC202 0001272010-001 RADNETMR1656 0002032011-001 407333EXTMR 0003072010-001 702254LVRMR 0003242009-001 JCI178 0004012010-001 201487ONI 0005152009-001 ZPR2185 0005262010-001 CALPAC003 0006012008-001 MHMH162 0006082010-001 SPRUCEEXT 0006182010-001 205930MR3 0007142009-001 POA187 0009142010-001 6150 0009172009-001 RADNETMR1641 0010182010-001 305CMI2 0011292010-001 513636EXTMR 0012052010-001 713791BONIMR 0012162008-001 HCH170 0012182008-001 916734EXMR 0007152011-001 MREQUINE3 SM12062013-002 718518MR430S 0008152010-001 0910272074 0008142012-001 AP4502MR01 0004082010-001 MR04082010 0005072010-001 MR05072010 0007082010-001 MR07082010 0007092010-001 MR07092010 0011242009-001 MR11242009 0012142009-001 MR12142009 0012152009-001 MR12152009 0003292011-001 EG1252MR02 0004192011-001 EG1524MR01 SM02042013-001 607849MR01 SM04292013-001 PC0127MR04 SM05062013-001 533398MR01 SM06092014-002 419793MR01 SM06182013-001 PC4318MR03 SM07182014-005 115530MR01 SM08152013-001 123701MR01 SM09132012-003 PC9982MR01 SM12122013-001 123955MR01 0001022012-001 PC0362MR03 0001152012-001 414456MR01 0001182010-001 PC7485MR01 0003012010-001 PY4178MR02 0003142012-007 761131MR01 0005132011-001 PC3756MR01 0006042009-001 PC5454MR01 0006062009-001 HC9457MR01 0006142012-001 805467MR01 0006212012-001 CC3829MR01 0006282012-010 PC0573MR03 0006302011-001 PC0075MR04 0007172012-001 654076MR01 0007232012-001 PC4712MR01 0007252012-001 PC1820MR01 0007272010-001 HC4201MR01 0008022011-001 PC3814MR03 0008142011-001 440719MR01 0009072009-001 PC8854MR01 0009092011-001 PC6543MR01 0009132010-001 PC1345MR01 0009172011-001 743862MR01 0010082010-001 TP0008MR03 0010082011-001 PKOB02MR05 0010172011-002 125995MR02 0011162010-001 126538MR02 0011202011-001 PC4529MR02 0012102011-001 788048MR01 SM02142014-001 123959MR01 SM07142014-002 PC4616MR01 0001182011-001 H10634MR11 0009062011-001 A5992702 0003302011-001 0834270017 0002182011-001 OSH02U875 0009222010-001…
FDA’s list runs to 2,514 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 2,514 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.