MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A
Medical device recall Z-1308-2015. Published in FDA’s Enforcement Report on Apr 1, 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 Apr 1, 2015. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 132 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 gradient output supervision was permanently turned off on the MAGNETOM system, meaning that gradient outputs could exceed IEC60601-2-33 limits and peripheral nerve stimulation could occur.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A ; indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis. The MAGNETOM systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-safe biopsy needles.
132, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
model numbers: 10432914, 10432915, 10684331, 10684332, 10684333, 10684334 with serial numbers: 45398 45788 59092 60099 41953 45805 52255 45812 52250 52171 52264 41980 41448 60092 41727 60038 60062 59071 59065 60061 60082 62032 41548 52168…
Every code shown here, 886 characters
model numbers: 10432914, 10432915, 10684331, 10684332, 10684333, 10684334 with serial numbers: 45398 45788 59092 60099 41953 45805 52255 45812 52250 52171 52264 41980 41448 60092 41727 60038 60062 59071 59065 60061 60082 62032 41548 52168 59032 62014 60086 57118 52108 41628 60070 45249 62027 41699 41701 59090 60060 60052 41903 52082 41473 45537 41749 41457 42060 41383 41769 45778 62018 45628 52200 42033 52135 52195 41317 41529 45371 57060 41862 59101 52150 52240 52128 41608 41624 42012 45160 45387 45603 45526 41476 45155 52251 41746 62020 41503 59120 62024 59096 62025 41897 59109 45681 41362 60053 60055 59087 60085 41819 59116 62031 52172 52057 52153 45623 59112 41844 41874 59104 45850 41621 52192 60054 41595 45667 41353 60063 57254 41556 60079 45408 41654 52021 52072 57146 45239 59035 59076 41629 41802 41952 45230 45251 41979 45237 45205 45694 41671 45507 41389 41295 60091
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.
Nationwide Distribution.
These words name no state.
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.
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 Mar 9, 2015.
- FDA classified it on Mar 20, 2015.
- FDA’s Enforcement Report published it on Apr 1, 2015.
- FDA terminated it on Aug 17, 2016.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc, of Malvern, PA.
- 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
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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.