SOMATOM Emotion 16
Medical device recall Z-2473-2018. Published in FDA’s Enforcement Report on Aug 8, 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 Aug 8, 2018. Copied from openFDA on Oct 20, 2026.
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?
A potential risk of unnecessary radiation exposure due to a software issue
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
SOMATOM Emotion 16 (10165977)
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial No. 32515 85907 32310 80551 32254 32156 32109 32319 80857 80640 80981 85661 85575 86359 32322 80849 32567 80413 86757 32370 32448 86521 32317 32504 86522 32568 80811 32190 85980 32490 32477 80525 80584 32552 80411 32587 86060 32526…
Every code shown here, 1,768 characters
Serial No. 32515 85907 32310 80551 32254 32156 32109 32319 80857 80640 80981 85661 85575 86359 32322 80849 32567 80413 86757 32370 32448 86521 32317 32504 86522 32568 80811 32190 85980 32490 32477 80525 80584 32552 80411 32587 86060 32526 85584 32185 32563 32364 32415 85765 32187 85756 85757 85657 32514 85913 80410 32295 32473 80988 86089 32120 80461 86405 32408 32512 32118 32309 32378 80475 32478 80531 32420 80755 85794 80876 80826 32123 32139 80836 80916 32159 80586 80862 80595 85875 32537 32472 80523 80519 80874 32401 80840 86286 86844 32605 32237 32674 32198 32673 80441 85520 80405 80762 85865 85641 85562 86431 86662 80795 85929 85543 32628 86022 32594 86368 85862 32461 85861 86401 80656 32326 80516 80873 32259 86360 86425 80706 80442 86429 32503 85656 86057 32334 80605 32407 32323 32124 32117 32229 32257 32375 32406 86284 32212 85960 86007 85852 85987 85999 32371 80444 86557 32298 85596 32315 32441 85653 32363 86013 32529 32532 32268 80548 32643 80976 80832 32200 32225 32244 85692 32221 32596 32252 32357 85538 80831 86320 32417 32452 32125 86032 32180 32126 32293 32227 32349 32641 32495 32427 32216 32581 80700 80498 85687 32573 85595 86605 80902 32591 80671 80467 86243 80600 80750 86714 80466 80518 80505 80530 32412 86208 80599 80937 86632 32637 32301 80973 32339 80479 32597 80430 32624 80815 86142 86292 86128 85842 86514 80927 32141 32277 32226 32424 32425 80659 32411 32391 32292 32127 86515 80637 80629 32281 32129 32492 32273 32469 85914 85795 32551 32213 80446 86287 32470 32320 85693 32402 80672 32324 32578 32531 32610 32488 32368 80485 80871 32215 32409 32376 80797 86357 80594 80474 32435 32432 86052 86285 80683 32346 80535 32270 80677 32493 32303 32580 80591 32328 32362 80823 32395 86358 32447 32169 80696 80526 80628 32589 32442
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
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 Feb 1, 2018.
- FDA classified it on Jul 28, 2018.
- FDA’s Enforcement Report published it on Aug 8, 2018.
- FDA terminated it on May 1, 2020.
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.