FDA Device recall Z-0015-2017
YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices
- FDA Device
- Class II
- terminated
- Published 2016-10-12
On 2016-10-12 the FDA classified a Class II recall of YSIO Max Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices by Siemens Medical Solutions Usa, citing 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 ca….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0015-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-08-01 |
| Published | 2016-10-12 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Siemens Medical Solutions Usa |
| Distribution | US |
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
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.
Identifiers
| code_info | Model Number: 10762470, 10893300, 10746665 Serial Numbers: 24644,24613,24615,40328,24611,24612,24614,40326,40322,40316…Model Number: 10762470, 10893300, 10746665 Serial Numbers: 24644,24613,24615,40328,24611,24612,24614,40326,40322,40316,24599,24600,40404,24634,2464124590,40402,1314,40312,24591,24592,40327,40323,24656,24659,40335,1315,40332,40403,24605,40325,40313,24645,24610,24580,24648,24581 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0015-2017%22
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