Siemens Ysio Max system The Ysio Max is a radiographic system used in… — Class II medical device recall Z-0002-2015
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2014-10-08, distributed nationwide. Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Ma
| Recall number | Z-0002-2015 |
|---|---|
| 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 | 2014-09-02 |
| Classified | 2014-10-02 |
| Reported by FDA | 2014-10-08 |
| Terminated | 2015-02-24 |
| Distributed | Nationwide (US) |
| Quantity | 10 |
| Reason classes | labeling, device malfunction |
| Serial numbers | 24014, 24015, 24016, 24024, 24025, 24026, 24028, 24033, 24034, 24037 |
Product
Siemens Ysio Max system The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max 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.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio Max system is not meant for mammography. The Ysio Max uses integrated or portable digital detectors for generating diagnostic images by converting x-rays into electronic signals. Ysio Max is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Reason for recall
Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an automatic Radiology Information System (RIS) worklist update, thus causing examinations to be repeated. Image label may also be displayed incorrectly after images
Machine access
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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.