Siemens Ysio Systems Product Usage: The Ysio — Class II medical device recall Z-1717-2014
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-06-11, distributed nationwide. Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, wh
| Recall number | Z-1717-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Siemens Medical Solutions USA, Inc, Malvern, PA, United States |
| Recall initiated | 2014-05-09 |
| Classified | 2014-06-04 |
| Reported by FDA | 2014-06-11 |
| Terminated | 2015-08-18 |
| Distributed | Nationwide (US) |
| Quantity | 433 |
| Reason classes | device malfunction |
| Serial numbers | 20034, 20045, 20047, 20088, 20089, 20093, 20094, 20105, 20106, 20107, 20110, 20112, 20113, 20115, 20149, 20155, 20167, 20185, 21001, 21004, 21005, 21006, 21013, 21023, 21031 and 408 more |
| Model numbers | 10281013, 10281163 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1717-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.