Recall Z-0987-2022 ยท OWB Interventional Fluoroscopic X-Ray System
Siemens Medical Solutions USA, Inc
Artis pheno- in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). Intended use-single and biplane diagnostic imaging and interventional procedures. Model: 10849000
| Date | Feb 25, 2022 |
| Status | Open, Classified |
| Reason | Five potential software issues affecting Artis pheno and Artis icono systems in combination with a Siemens Healthineers table or Trumpf/MAQUET table (OEM). The potential software errors are related to the block movements function and manual rotation of the flat detector. Depending on the status of the intervention, the limited functionality may not be sufficient to continue with treatment as planned. This may result in a situation where clinical treatment may be delayed until an additional restart is performed |
| Root cause | Software Design Change |
| Action | Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to all affected customers via AX005/22/S on 2/28/22. Siemens will provide a software update for all affected systems via Update Instruction AX003/22/S and AX004/22/S. Letter states reason for recall, health risk and action to take: We do not consider it necessary to re-examine any patients in relation to the issues (issue 1 to 5) described above. If measurements have already been performed in the past for diagnostics, please verify the results and diagnostic evaluation if applicable. Siemens will correct the so |
| Quantity | 20 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K201156 | ARTIS pheno (VE2) Siemens Medical Solution USA, Inc., Jun 29, 2020 |