Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that…
Medical device recall Z-0199-2019. Published in FDA’s Enforcement Report on Oct 31, 2018.
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 Oct 31, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 41 states named in where it went
- 252 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 using respiratory gating with Steady Mode ON in Spin Echo sequence scanning, the SAR (Specific Absorption Rate) value displayed on the console may be lower than the actual SAR value. The actual applied SAR values may exceed the FIRST LEVEL CONTROLLED OPERATING MODE.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Nuclear Magnetic Resonance Imaging Systems that are indicated for use as a diagnostic imaging modality that produces cross-sectional transaxial, coronal, sagittal, and oblique images that display anatomic structures of the head or body.
252, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
MODEL SERIAL NUMBER SID MEXL-1504/U4 U4A12Z2020 30005914 MEXL-1504/T4 S4D1132069 339325 MEXL-1504/S4 S4A1032017 326165 MEXL-1504/U4 U4A1312023 30000547 MEXL-1504/S4 S4A1032019 327601 MEXL-1504/U4 U4A1312024 30002325 MEXL-1504/T4 S4D1152082…
Every code shown here, 1,997 characters
MODEL SERIAL NUMBER SID MEXL-1504/U4 U4A12Z2020 30005914 MEXL-1504/T4 S4D1132069 339325 MEXL-1504/S4 S4A1032017 326165 MEXL-1504/U4 U4A1312023 30000547 MEXL-1504/S4 S4A1032019 327601 MEXL-1504/U4 U4A1312024 30002325 MEXL-1504/T4 S4D1152082 330035 MEXL-1504/S4 S4A1082040 330134 MEXL-1504/A4 A4A11Z2011 346866 MEXL-1504/U4 U4A1282003 356105 MEXL-1504/U4 U4A1322025 30009003 MEXL-1504/U4 U4B1442070 30012516 MEXL-1504/U4 U4A1352035 389636 MEXL-1504/U4 U4B1552097 30010318 MEXL-1504/U4 U4A12X2010 351817 MEXL-1504/S4 S4C1112065 330381 MEXL-1504/S4 S4C1112064 334599 MEXL-1504/A4 A4A11Z2009 352039 MEXL-1504/S4.004 S4A1072033 30025756 MEXL-1504/S4 S4A09Y2002 345231 MEXL-1504/U4.004 U4A1282002 30027784 MEXL-1504/U4.004 U4A1382047 30036224 MEXL-1504/S3 S3A0972030 312421 MEXL-1504/U4 U4A12X2011 345074 MEXL-1504/S4 S4C1112061 337212 MEXL-1504/U4 U4A13X2054 30011038 MEXL-1504/A4 A4A1222015 351023 MEXL-1504/U4 U4A1322026 337071 MEXL-1504/U4 U4B1642106 30008395 MEXL-1504/A4 A4A1222017 347963 MEXL-1504/S4 S4A10X2047 315713 MEXL-1504/S3 S3A08Z2019 303586 MEXL-1504/U4 U4B1522092 358163 MEXL-1504/A4 A4A11X2004 30018147 MEXL-1504/T4 S4D1132074 347260 MEXL-1504/U4 U4B1422064 30021502 MEXL-1504/U4 U4A1312022 30004266 MEXL-1504/U4 U4A1352036 30001882 MEXL-1504/U4 U4A1372046 337083 MEXL-1504/T4 S4D1142076 341529 MEXL-1504/U4 U4A13Z2057 30005810 MEXL-1504/A4 A4A11Z2010 349167 MEXL-1504/U4 U4A1292007 349175 MEXL-1504/U4 U4B1632105 366015 MEXL-1504/U4 U4B1492081 376523 MEXL-1504/U4 U4A1352037 389696 MEXL-1504/U4 U4A1312021 353532 MEXL-1504/U4 U4B1482077 392326 MEXL-1504/A4 A4A11X2002 333633 MEXL-1504/U4 U4B14Y2082 30018555 MEXL-1504/U4 U4A13X2051 325434 MEXL-1504/A4 A4A11Y2006 350868 MEXL-1504/A4 A4A1252024 356295 MEXL-1504/U4 U4B1532094 30027785 MEXL-1504/U4 U4B1652107 30009792 MEXL-1504/S3 S3A0922023 299545 MEXL-1504/U4 U4A1382049 30007016 MEXL-1504/U4 U4A12Z2014 356808 MEXL-1504/S3 S3A0892009 301747 MEXL-1504/A4 A4A11X2003 324905 MEXL-1504/S3.004 S3A0882007 30024991 MEXL-1504/T4 S4D1132073…
FDA’s list runs to 8,033 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.
Domestic: AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT, WA, WI, WV, and WY. International: Algeria, Australia, Bangladesh, Brazil, Canada, China, Colombia, Congo, Dominican Republic, Egypt, Guinea, Honduras, India, Indonesia, Iran, Japan, Kenya, Korea, Lebanon, Malaysia, Mexico, Morocco, Netherlands, Nigeria, Oman, Pakistan, Paraguay, Qatar, Saudi Arabia, Singapore, South Africa, Sudan, Taiwan, Thailand, Turkey, UAE, and Vietnam
The states and territories these words name
41 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 30, 2018.
- FDA classified it on Oct 22, 2018.
- FDA’s Enforcement Report published it on Oct 31, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Canon Medical System, USA, INC., of Tustin, CA.
- 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 8,033 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
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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.