Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic exposures f 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.

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

On January 8, 2020, the firm notified customers of the product issue via an Urgent Medical Device Correction letter. Customers were instructed to ensure that the image displayed after acquisition is a newly acquired image and belongs to the current patient. If the error occurs and a previously acquired image is duplicated, the user should delete the image and contact Siemens Customer Service at 1-800-888-7436 to report the incident. Siemens Healthineers will correct the error with a field software update which will be available beginning January 2020. Your local Siemens Healthineers Service organization will contact you to arrange a date to perform this corrective action when the software update is available for your system. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436.