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Recall Observatory FDA recall evidence

Device 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.

Z-0015-2017

August 01, 2016

Class II

Product summary

Firm
Siemens Medical Solutions USA, Inc
Event
Event 75126
Status
Terminated
Classification
Class II
Quantity
37 Systems
Official record key
device-enforcement:Z-0015-2017

Official wording

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.

Code information: 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

Distribution pattern: US Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.