FDA-Device2022-07-06Class II
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Siemens Medical Solutions USA, Inc
Hazard
A video signal from one of the transceivers of the Large Display may be lost. In very rare cases, both transceivers of the Large Display could potentially fail which can lead to the loss of both video signals. This issue can sporadically affect the Large Display in the examination room as well as the displays in the control room.
Sold states
Domestic distribution nationwide. Foreign distribution to Australia Austria Belgium Brazil Canada China Colombia Denmark Finland France Germany Hungary Indonesia Iran Italy Japan Kuwait Mexico Monaco Netherlands Norway Poland Singapore Slovakia South Africa Spain Sweden Switzerland Taiwan Thailand Turkey United Arab Emirates United Kingdom United States Vietnam
Affected count
136 systems
Manufactured in
40 Liberty Blvd, Malvern, PA, United States
Products
Artis Pheno, Interventional Fluoroscopic X-Ray System, Model No. 10849000
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2022Don't want to check this manually?
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