Recall Z-1243-2022 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Sensis, Programmable Diagnostic Computer, Model Nos. 6623974 6634633 6634658 6648153 6648161 10140973 10764561 10765502 10910620
| Date | Jun 6, 2022 (initiated Apr 13, 2022) |
| Status | Open, Classified |
| Reason | Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system. |
| Root cause | Software Design Change |
| Action | On April 13, 2022, the firm notified customers via an Urgent Medical Device Correction letter. Customers were informed of the software issues. the software in the affected systems will be updated to correct the issue. Siemens' service organization will contact customers to arrange a date to perform the corrective action. Please feel free to contact Siemens' service organization for an earlier appointment at 1-800-888-7436. |
| Quantity | 443 |
| Distribution | Domestic 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 |