Recall Z-2680-2014— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-2680-2014
Creator: U.S. Food and Drug Administration
Published: 2014-08-27

Class II · Terminated

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2014-08-27, terminated 2015-03-30. It names one FDA 510(k) clearance: K081722. Product: The Ysio Systems with software version VC10 The Ysio 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.. Reason: Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Terminated
Initiated: 2014-08-27
Terminated: 2015-03-30
Firm location: Malvern, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K081722 — YSIOSiemens Medical Solutions USA, Inc.·cleared 2008-08-22

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

The Ysio Systems with software version VC10 The Ysio 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.

Reason for recall

Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may need to be repeated.

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