Recall Z-0683-2024 ยท DQK Computer, Diagnostic, Programmable
Siemens Medical Solutions USA, Inc
Sensis Vibe Hemo
| Date | Jan 9, 2024 (initiated Nov 29, 2023) |
| Status | Open, Classified |
| Reason | The possibility of the Sensis documentation functionality application to crash. |
| Root cause | Software design |
| Action | The recalling firm issued an URGENT: MEDICAL DEVICE CORRECTION notification dated 11/29/23 by mail to consignees to notify them of this recall event. In the case this failure mode occurs during use, consignees are asked to continue the exam by opening a new study for the same patient without adding any Type 1 reporting events. It is instructed that consignees can compensate this by adding free text comments (procedure notes) only and manually inserting the desired information in those comments. The recalling firm will deploy a software update via Update Instruction AX010/23/S to correct the er |
| Quantity | 331 units |
| Distribution | Domestic: CA, CT, & FL. |
| 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 |