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
245762407725409241002421324051245312454224038241162569925698250892507625297254772505624644242212571725647257162425624572253662542525020246162427525444244332453624340244372403325392250062555425506256442566625164256192515625677250382515125152244012512525093242912536924622246242462924630246352463624637
- Serial Numbers
- 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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