Recall Z-1339-2020— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-1339-2020
Creator: U.S. Food and Drug Administration
Published: 2020-01-08

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2020-01-08, terminated 2022-06-21. It names one FDA 510(k) clearance: K133259. Product: 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.. Reason: A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2020-01-08
Terminated: 2022-06-21
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K133259 — YSIO MAXSiemens Medical Solutions USA, Inc.·cleared 2014-01-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.