Reported Aug 12, 2020 · Terminated
SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System, Model: 10762470 - Product Usage: is a device…
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
Is this the product you have?
- SIEMENS Healthineers Ysio Max - Interventional Fluoroscopic X-Ray System
- Model10762470 -
- Product Usageis a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image
- Lot codes and dates
- Serial Numbers
512 of 512 codes
245762407725409241002421324051245312454224038241162569925698250892507625297254772505624644242212571725647257162425624572253662542525020246162427525444244332453624340244372403325392250062555425506256442566625164256192515625677250382515125152244012512525093242912536924622246242462924630246352463624637
- Serial Numbers
- Amount recalled
- 512 units
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
- Nationwide
Why it was recalled
Two software issues (1) Using the override function in case of blocked system movements affecting Luminos dRF Max, Luminos Agile Max and Uroskop Omnia Max systems may cause collision of the system under operator control with obstacles or persons .(2) Incorrectly assigned image affecting Ysio Max, Luminos dRF Max and Luminos Agile Max systems with detector MAX Static causing incorrect base for diagnosis
This product could cause temporary or reversible health problems — stop using it.
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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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