Reported Apr 6, 2022 · Ongoing

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

Siemens Medical Solutions USA, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Medical Solutions USA, Inc · 40 Liberty Blvd · Malvern, PA · 19355-1418

Is this the product you have?

    • Ysiosystem with VC10 software version
    • Model Number 10281013. Radiographic system
Lot codes and dates
  • Serial Numbers

    70 of 70 codes

    • 20113
    • 23071
    • 20118
    • 22523
    • 23021
    • 22169
    • 23164
    • 22388
    • 22119
    • 22844
    • 21209
    • 23699
    • 21114
    • 22190
    • 22146
    • 22126
    • 22128
    • 22836
    • 22163
    • 22727
    • 22135
    • 22347
    • 21174
    • 22676
    • 22029
    • 22895
    • 22917
    • 22920
    • 22058
    • 22847
    • 22852
    • 22655
    • 22708
    • 22275
    • 22254
    • 22928
    • 22857
    • 22208
    • 22071
    • 23130
    • 22092
    • 22175
    • 21194
    • 23602
    • 23018
    • 23019
    • 22076
    • 22630
    • 21108
    • 22919
    • 22825
    • 22054
    • 22177
    • 20105
    • 22998
    • 20115
    • 22104
    • 22966
    • 23625
    • 23627
Amount recalled
70 Systems

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 5:34 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.