Siemens Medical Solutions USA, Inc Recall 88412
Description: Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging
Siemens Medical Solutions USA, Inc Recall 88412 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2404-2021 |
| Event ID | 88412 |
| Event Description | Artis Models with SW version VD12 listed below: Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee MP 10094139 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Angiography systems developed for single and biplane diagnostic imaging |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, ND, NE, NH, NJ, NV, NY, OH, PA, TN, TX, UT, VA, WA, WI. |
| Quantity | 70 US (172 WW) |
| Recall Reason | Due to a software error, the IAS (Image Acquisition System) may sporadically fail during startup/ restart, and result in delay of clinical treatment |
| Device Classification | 20210908 |
| Device Code Info | Units with SW version VD12 Serial Numbers: 104005 104007 104012 104013 105500 105501 109645 110001 110005 110006 110007 110014 110016 110017 110018 110022 110023 110024 110025 110026 110027 110031 110032 110035 110036 110037 110039 110040 110041 110042 110043 110044 110046 110048 110051 111133 111500 111501 111502 111503 111504 111505 111506 111507 111508 111510 122001 122002 122005 122007 123501 123502 139012 150002 150003 150005 150009 150011 159010 159015 159021 159024 159025 159026 159028 159030 159032 159034 159037 159038 |
| Center Classification Date | 20210902 |
| Recall Initiation Date | 20210630 |
| Recalling Firm | Siemens Medical Solutions USA, Inc |
| Initial Notification | Letter |
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