Recall Z-0841-2022— Siemens Medical Solutions USA, Inc

Name: FDA recall Z-0841-2022
Creator: U.S. Food and Drug Administration
Published: 2022-01-31

Class II · Ongoing

Class II FDA medical device recall by Siemens Medical Solutions USA, Inc, initiated 2022-01-31. It names one FDA 510(k) clearance: K081722. Product: Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system. Reason: Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons..

Recalling firm: Siemens Medical Solutions USA, Inc
Classification: Class II
Status: Ongoing
Initiated: 2022-01-31
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

Ysiosystem with VC10 software version, Model Number 10281013. Radiographic system

Reason for recall

Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a longitudinal or transversal movement at the time of the error, the system controls may initiate a correction of the tube stand position, resulting in an unintended movement. If the described error occurs, a potential for collision risk for objects or persons in the vicinity of the moving stand exists. This may result in minor to serious injuries to persons.

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