Siemens Medical Solutions USA, Inc Recall 90401
Description: Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
Siemens Medical Solutions USA, Inc Recall 90401 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1342-2022 |
| Event ID | 90401 |
| Event Description | Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600 |
| Product Type | Devices |
| 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 Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam. |
| Quantity | 195 worldwide, 88 US |
| Recall Reason | 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. |
| Device Classification | 20220713 |
| Device 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 |
| Center Classification Date | 20220706 |
| Recall Initiation Date | 20220520 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | N/A |
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