YSIO Max Product Usage: The Ysio Max is a radiographic system used in… — Class II medical device recall Z-0015-2017
Terminated recall by Siemens Medical Solutions USA, Inc, reported 2016-10-12, distributed nationwide. Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There
| Recall number | Z-0015-2017 |
|---|---|
| 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 | 2016-08-01 |
| Classified | 2016-10-03 |
| Reported by FDA | 2016-10-12 |
| Terminated | 2016-12-13 |
| Distributed | Nationwide (US) |
| Quantity | 37 systems |
| Reason classes | device malfunction |
| Serial numbers | 1314, 1315, 24580, 24581, 24591, 24592, 24599, 24600, 24605, 24610, 24611, 24612, 24613, 24614, 24615, 24634, 2464124590, 24644, 24645, 24648, 24656, 24659, 40312, 40313, 40316 and 11 more |
| Model numbers | 10746665, 10762470, 10893300 |
Product
YSIO Max Product Usage: 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.
Reason for recall
Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could result in an injury to a patient on the table.
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-0015-2017. 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.