Recall Z-0226-2022 ยท MUQ Glue, Surgical, Arteries
Siemens Medical Solutions USA, Inc
Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies
| Date | Oct 5, 2021 |
| Status | Open, Classified |
| Reason | System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs |
| Root cause | Software design |
| Action | Siemens Medical Solutions USA, Inc. initiated a Customer Safety Advisory Notice to customers via AX067/21/S dated 10/5/21. Letter states reason for recall,health risk and action to take: The software in the affected systems will be updated to display a notification message. Once the system has reached a runtime of more than 7 days, a notification message will be displayed after closing a study to remind the operator to reboot the system as it is running longer than advised. In addition, the system operating manual will include a warning message that the Sensis system can have performance is |
| Quantity | 403 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150493 | Sensis Siemens Medi Cal Solutions, Inc., Jun 30, 2015 |