Reported Feb 26, 2020 · Terminated

Ysio Max, model no. 10762470 - Product Usage: The Ysio Max is a radiographic system used in hospitals, clinics, and…

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 Max, model no. 10762470 -
  • Product UsageThe Ysio Max is a radiographic system used in hospitals, clinics, and medical practices. Ysio Max enables radiographic and tomographic
  • exposures f 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.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Ysio max system is not meant for mammography
Lot codes and dates
  • Serial Numbers

    507 of 507 codes

    • 24576
    • 24077
    • 25409
    • 24100
    • 24213
    • 24051
    • 24531
    • 24542
    • 24038
    • 24116
    • 25699
    • 25698
    • 25089
    • 25076
    • 25297
    • 25477
    • 25056
    • 24644
    • 24221
    • 25717
    • 25647
    • 25716
    • 24256
    • 24572
    • 25366
    • 25425
    • 25020
    • 24616
    • 24275
    • 25444
    • 24433
    • 24536
    • 24340
    • 24437
    • 24033
    • 25392
    • 25006
    • 25554
    • 25506
    • 25644
    • 25666
    • 25164
    • 25619
    • 25156
    • 25677
    • 25038
    • 25151
    • 25152
    • 24401
    • 25125
    • 25093
    • 24291
    • 25369
    • 24622
    • 24624
    • 24629
    • 24630
    • 24635
    • 24636
    • 24637
Amount recalled
507

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was recalled

A software bug may lead to one image to be assigned to two different patients, which could potentially affect medical diagnosis.

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 Jun 21, 2022 · Data as of Sep 19, 4:51 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.