Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Check against the official notice below — it lists the full affected range.
Siemens Medical Solutions USA, Inc. is recalling the Artis Icono Interventional Fluoroscopic X-Ray System (Model No. 11327600) due to increased wearing of the Image acquisition system fans that has been observed during system tests. This wearing could lead to an electrical failure, which may cause the image system to malfunction during regular operation.
The recall affects 195 devices worldwide, including 88 in the United States distributed across 33 states and multiple countries internationally. The recalled systems are identified by UDI-DI 04056869063317 and specific serial numbers ranging from 180014 to 180407. The source document does not specify a remedy or required action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation.
Reason for recall: During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may cause malfunction of the image system during regular system operation. Distribution: Domestic distribution to AL, AR, AZ, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MA, MD, MI, MO, MT, NC, NE, NJ, NY, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI and the countries of Armenia, Australia, Austria, Belgium, Canada, China, Denmark, Finland, France, Germany, Greece, Hong Kong, Ireland, Israel, Japan, Kazakhstan, Netherlands, New Zealand, Norway, Oman, Saudi Arabia, Singapore, South Africa, South Quantity: 195 worldwide, 88 US Lot/code info: UDI-DI: 04056869063317 Serial Numbers: 180062 180054 180019 180065 180056 180057 180041 180317 180034 180072 180349 180367 180382 180060 180399 180337 180070 180048 180083 180369 180370 180371 180372 180345 180315 180343 180080 180301 180305 180067 180330 180040 180379 180386 180360 180333 180029 180352 180336 180407 180400 180397 180316 180068 180363 180084 180334 180018 180350 180376 180354 180046 180047 180335 180085 180035 180339 180357 180358 180361 180362 180081 180331 180381 180021 180342 180321 180309 180356 180378 180393 180368 180341 180323 180329 180043 180049 180377 180077 180086 180053 180055 180015 180014 180066 180082 180037 180373
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.