Siemens Medical Solutions USA, Inc Recall 87620
Description: Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients.
Siemens Medical Solutions USA, Inc Recall 87620 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1497-2021 |
| Event ID | 87620 |
| Event Description | Interventional Fluoroscopic X-Ray System ARTIS icono biplane- 11327600 ARTIS icono floor- 11327700 ARTIS pheno- 10849000 ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. |
| Product Type | Devices |
| Distribution | Worldwide distribution: US (nationwide) including states of: CA, CO, DE, FL, IL, IN, KY, MD, MI, NC, NE, NJ, NY, OH, TN, TX, UT, WI, and OUS (countries) of: AT, BE, ES, IT, FI, CH, FR, GB, SE, DE, DK, IE and NL. |
| Quantity | 133 systems |
| Recall Reason | Siemens has become aware of a potential issue with software version VE20C. Planned procedures may have to be terminated and performed on an alternative x-ray system. |
| Device Classification | 20210505 |
| Device Code Info | Software VE20C serial #s 180062 170319 180317 180072 180060 180048 180083 180315 170305 180080 180301 180305 180330 170307 180040 180333 170309 170310 170304 180316 180334 170025 180047 180085 180331 180321 180309 170312 180323 164703 170303 180329 180015 180014 180037 |
| Center Classification Date | 20210426 |
| Recall Initiation Date | 20210319 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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