Recall Z-2441-2024 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 11007641
| Date | Jul 25, 2024 (initiated Jul 3, 2024) |
| Status | Open, Classified |
| Reason | If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash. |
| Root cause | Software design |
| Action | Siemens issued Urgent Medical Deice Correction letter (AX038/23/S-C) on 7/3/24 to Director of Diagnostic Imaging and/or Radiology Laboratory. Letter states reason for recall, health risk and action to take: If the Sensis documentation functionality is used and the described scenario occurs, users should continue the exam by opening a new study for the same patient without adding any Type 1 reporting events. You can compensate this by adding free text comments (procedure notes) only and manually inserting the desired information in those comments. Please ensure that patient treatment can be con |
| Quantity | 12 units |
| Distribution | US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223812 | Sensis Vibe (VD15) Siemens Medical Solutions USA, Inc., Sep 15, 2023 |