Recall Z-1342-2022 ยท JAK System, X-Ray, Tomography, Computed
Siemens Medical Solutions USA, Inc
Artis Icono, Interventional Fluoroscopic X-Ray System, Model No. 11327600
| Date | May 20, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 195 worldwide, 88 US |
| 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, Jap |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193326 | ARTIS Icono Siemens Medical Solutions USA, Inc., Apr 16, 2020 |