Reported Mar 25, 2020 · Terminated

Ysio, model no. 10281013 Product Usage: The product is a stationary X-Ray 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?

  • Ysio, model no. 10281013
  • Product UsageThe product is a stationary X-Ray system
Lot codes and dates
  • Serial Nos.

    81 of 81 codes

    • 20113
    • 20034
    • 21100
    • 21086
    • 21113
    • 21088
    • 21103
    • 21221
    • 21223
    • 21224
    • 21085
    • 20045
    • 20093
    • 20110
    • 21066
    • 21031
    • 21139
    • 21006
    • 20155
    • 21112
    • 21122
    • 21185
    • 20088
    • 20089
    • 20106
    • 20107
    • 21052
    • 21089
    • 21213
    • 20167
    • 21098
    • 21174
    • 21057
    • 21101
    • 21116
    • 21117
    • 21118
    • 21120
    • 21091
    • 21092
    • 21037
    • 21076
    • 21077
    • 21200
    • 21203
    • 21209
    • 20149
    • 21163
    • 21172
    • 21171
    • 21173
    • 20094
    • 21115
    • 20047
    • 21194
    • 20193
    • 21211
    • 21212
    • 21186
    • 21188
Amount recalled
81 US/ 308 worldwide

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

Why it was recalled

The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote console), the systems controls may (depending on the values being processed) initiate a correction of the tube stand position, resulting in an unexpected movement.

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

Notice updated Aug 31, 2020 · Data as of Sep 19, 5:30 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.