Reported Jun 11, 2014 · Terminated

Siemens Ysio Systems Product Usage: The Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals,…

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?

  • Siemens Ysio Systems Product UsageThe Ysio (New RAD-FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic
  • exposures of the whole body includingskull, 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.) ad emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio System is not meant for mammography. The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography *CR) cassettes
Lot codes and dates
  • Model nos. 10281013,10281163 with serial nos.

    433 of 433 codes

    • 30080
    • 23071
    • 20045
    • 31072
    • 22523
    • 22776
    • 22787
    • 31137
    • 23021
    • 20034
    • 20112
    • 22775
    • 22279
    • 22283
    • 22280
    • 22875
    • 22290
    • 22576
    • 22848
    • 31060
    • 31136
    • 31064
    • 31138
    • 22326
    • 23068
    • 22288
    • 22114
    • 22714
    • 21100
    • 22960
    • 23082
    • 22169
    • 22601
    • 21065
    • 21205
    • 31017
    • 31135
    • 31040
    • 21086
    • 22972
    • 30038
    • 30047
    • 23029
    • 22538
    • 22658
    • 21088
    • 21103
    • 31120
    • 21224
    • 21221
    • 21223
    • 21085
    • 31122
    • 22597
    • 22388
    • 22391
    • 20115
    • 22104
    • 22583
    • 23097
Amount recalled
433

This recall covers 3 products

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Where it was sold

  • Nationwide

Why it was recalled

Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation.

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

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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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 18, 2015 · Data as of Sep 19, 4:52 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.