V5Ms Transesophageal transducers
Medical device recall Z-2571-2014. Published in FDA’s Enforcement Report on Sep 10, 2014.
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 Sep 10, 2014. 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
- 321 units 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?
Reports of deterioration of material covering the articulating section of the V5Ms transesophageal transducer.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
V5Ms Transesophageal transducers; V5Ms trans-esophageal echocardiograph (TEE) ultrasound transducer is intended primarily for cardiology applications
321 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model numbers 8264577 and 8263703; Serial numbers: US: 33707625 32807460 34507747 42208166 S34707777 32907477 33007494 33307538 33507577 33507584 33707612 34107671 34707781 40908018 41508085 41608100 41908126 41908129 S34607757 S34907818…
Every code shown here, 1,992 characters
Model numbers 8264577 and 8263703; Serial numbers: US: 33707625 32807460 34507747 42208166 S34707777 32907477 33007494 33307538 33507577 33507584 33707612 34107671 34707781 40908018 41508085 41608100 41908126 41908129 S34607757 S34907818 33907638 33907642 34807802 33007497 34207690 34307704 34607760 40607983 41808117 41908127 35107862 35107863 40107882 40407947 S34307696 33707631 34207694 33007487 41508082 41608089 34707771 41708101 33207509 33207519 33207522 33707622 34907824 35107872 40107896 42008137 33207520 41708109 S34607755 33307537 33607596 33707619 34607768 41808119 33707630 42008136 40407946 34207680 34607762 40808002 41008037 41708108 S33207505 33507578 41108046 41308062 42008132 34307703 34707778 40307937 40407951 40808007 41908128 40207906 32907474 33307539 34607758 35107875 40908017 41308054 41508088 41508080 41508087 33507576 33607590 33707621 40407958 40607982 41008032 41808118 42208161 42208163 41408065 33207513 33407545 33507575 33707615 33707624 34207693 34707785 35107867 35107868 40307938 40707986 S33007483 S33707609 40307940 42208165 41108044 42108156 42108157 41508076 42008133 34307712 34007659 32807451 32807459 34207678 34307702 34707787 34907832 40607979 40607980 41808120 41908125 32807454 33707614 41008033 34407716 34707776 S33007481 S34307698 S34407722 33507569 34607764 34907840 40707991 40407944 33907651 33907633 34807811 34907838 34207695 41108041 S34307700 33407553 35007855 40407949 40307924 40307927 S33307527 32907479 33007498 33507582 33907635 34007662 34707782 34907831 40407955 41608096 40707988 ROW: 35007853 40807999 34307711 40607974 40207909 34607767 40307933 33407548 40107885 34507743 33907648 42108150 40207910 33607599 32907471 35107859 40707992 41608093 40507963 34807806 40107887 41008038 33907636 34807807 41008034 34807810 S34007656 S34607750 33707607 33507572 34807805 42108154 40207913 42108144 40807998 42108145 33907640 33207510 40707985 40107900 34707779 40707984 35007847 40107890 40507966 41108042 40207903 42008134…
FDA’s list runs to 2,988 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.
Worldwide Distribution - USA (nationwide) and Internationally tAustralia, Austria, Belgium, Bolivia, Brazil, Canada, China, Columbia, France, Germany, Great Britain, India, Ireland, Italy, Japan, Mexico, Netherlands, Norway, Peru, Poland, Portugal, Russian Federation, Saudi Arabia, Slovak Republic, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand,and United Arab Emirates.
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.
The words say it went outside the United States too.
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 Aug 13, 2014.
- FDA classified it on Sep 3, 2014.
- FDA’s Enforcement Report published it on Sep 10, 2014.
- FDA terminated it on Mar 6, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Siemens Medical Solutions USA, Inc., of Mountain View, 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 2,988 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.