Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in…
Medical device recall Z-1717-2014. Published in FDA’s Enforcement Report on Jun 11, 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 Jun 11, 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
- 433 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?
Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes.
433, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model nos. 10281013,10281163 with serial nos. 30080 23071 20045 31072 22523 22776 22787 31137 23021 20034 20112 22775 22279 22283 22280 22875 22290 22576 22848 31060 31136 31064 31138 22326 23068 22288 22114 22714 21100 22960 23082 22169…
Every code shown here, 1,996 characters
Model nos. 10281013,10281163 with serial nos. 30080 23071 20045 31072 22523 22776 22787 31137 23021 20034 20112 22775 22279 22283 22280 22875 22290 22576 22848 31060 31136 31064 31138 22326 23068 22288 22114 22714 21100 22960 23082 22169 22601 21065 21205 31017 31135 31040 21086 22972 30038 30047 23029 22538 22658 21088 21103 31120 21224 21221 21223 21085 31122 22597 22388 22391 20115 22104 22583 23097 22943 22942 22585 22781 21089 20093 20110 21066 22404 22796 22506 21031 30040 22119 22599 22844 22148 22880 21139 21006 20155 30055 30024 21114 21112 21122 31069 21185 30051 31078 30076 31012 22429 22190 31010 31011 22146 22527 22520 22126 22128 23138 31018 22836 23083 23036 22163 20089 20107 20088 20106 21052 22727 23098 22135 22737 22872 22542 22549 22551 22567 22500 31075 22449 30032 22350 31128 22389 31004 22984 30028 23020 31026 31134 21213 22247 22347 30078 22428 22137 22917 22873 31115 20167 31053 31081 21174 22029 22725 22724 31094 22286 31019 22093 22933 22920 22895 22681 22676 22682 22019 22020 21098 31077 31119 30062 31054 22080 31121 30050 21057 22833 22840 22955 31093 22058 31046 22931 22847 22852 22309 21101 22612 21120 21117 21116 21118 22367 22600 22946 30021 22655 22705 23016 22699 22192 22251 22899 31028 21091 31071 22928 22275 21092 22254 21037 21077 21076 22839 22117 22609 22543 22821 30029 23118 22838 22842 21200 21209 21203 20149 21163 22708 21172 21171 21173 22248 31067 31066 23053 30066 30067 30063 22789 22857 22055 22050 22038 22051 22056 22037 22060 22242 22071 22208 22073 22632 22683 22666 22541 22537 22364 23127 23129 20094 22132 22026 22027 22225 23024 23022 30052 23130 23132 22092 21115 22456 22441 22021 22730 22743 22851 21113 22175 31003 22584 20047 21194 22786 31117 31145 23018 23019 22166 22170 22944 22945 31079 23038 22869 31103 31104 31095 31047 20113 30023 30027 30019 23113 22431 22778 22777 23047 21212 21211 23035 22216 23066 30037 22861 22859 22824 22755 22757 22693 22647 21188 21186 22656 21094 22390 21040 21039 22076 22630…
FDA’s list runs to 2,643 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 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 May 9, 2014.
- FDA classified it on Jun 4, 2014.
- FDA’s Enforcement Report published it on Jun 11, 2014.
- FDA terminated it on Aug 18, 2015.
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.”
- FDA’s list of codes runs to 2,643 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.