Siemens Medical Solutions USA, Inc Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Brand
Siemens Medical Solutions USA, Inc
Lot Codes / Batch Numbers
Not specified in FDA notice. Check official source for details.
Products Sold
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
Siemens Medical Solutions USA, Inc is recalling Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 due to During system tests, an increased wearing of the Image acquisition system fans has been observed. This could lead to an electrical failure which may c. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
On May 20, 2022, the firm sent Urgent Medical Device Correction letters to affected customers. Customers were informed that in the event this issue occurs, the system will switch to Bypass fluoroscopy mode. In Bypass fluoroscopy mode a limited imaging functionality (non-subtracted, continuous fluoroscopy with reduced power and without acquisition and storage of images) would remain available. This may result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. Customer Instructions: In the event you recognize a high squeaking scratching loud noise out of one of the system cabinets, please contact your service partner for immediate action. It is recommended to avoid performing any critical interventions on the system. Due to the possible risk of electrical shock to the technician, please ensure that your service partner (if not Siemens Healthineers) first contacts Siemens Healthineers' service organization before starting any corrective actions. The firm will replace the affected parts. The service organization will contact customers to arrange a date to perform the corrective action. To schedule an earlier appointment, contact the firm at 1-800-888-7436.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, AZ, AR, CA, CO, CT, DE, FL, ID, IL, IN, KY, LA, MD, MA, MI, MO, MT, NE, NJ, NY, NC, OH, PA, RI, SC, SD, TN, TX, UT, VA, WI
Page updated: Jan 10, 2026