Reported Dec 20, 2023 · Ongoing
ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
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?
- ARTIS icono (ceiling configuration), Fluoroscopic x-ray system; Model no. 11328100
- Lot codes and dates
- UDI-DI 04056869295923 Serial NumbersAll SN's associated with material number 11328100
- Amount recalled
- 38 worldwide, 11 US
Where it was sold
Why it was recalled
Potential hardware issue for ARTIS icono ceiling system: collision sensor may falsely signal non-existing collisions for up to half an hour when the system is switched off for a longer time (e.g., overnight) and switched on. During this time, system movement is only possible with the "override" function with very slow speed and without further collision protection. This may lead to temporary unavailability of the system for diagnostic and therapeutic usage.
This product could cause temporary or reversible health problems — stop using it.
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