Reported Aug 12, 2020 · Terminated
SIEMENS Healthineers Luminos Agile Max Model: 10762472 - Product Usage: is a device intended to visualize anatomical…
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 Luminos Agile Max Model10762472 -
- 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
477 of 477 codes
612036175161085617556185861786617956103461127616026121261053611946169961757617526120061738617996187561603616246188561848612436160661682610876188861052618896122661854610796121861110611376112361763616216162261623617886179861837618926119361700617436165261229610456183861239616326119061013616596110261724
- Serial Numbers
- Amount recalled
- 477 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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