Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Wo
FDA device recall Z-1434-2021 · posted 2021-04-19 · Terminated
Recall details
- Recalling firm
- Siemens Medical Solutions USA, Inc
- Reason for recall
- Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions
- Action taken
- Siemens Healthineers issued Customer Safety Advisory Notice dated 3/4/21 to affected customers via AX074/20/S. Letter states reason for recall, health risk and action to take: Siemens will restrict the Windows Service Permissions to the required level only and the IT security vulnerability of your system will be reduced via Update Instruction AX073/20/S. Our service organization will contact you shortly to arrange a date to perform this corrective action. Please feel free to contact our service organization for an earlier appointment at 1-800-888-7436. Please review, understand, and confirm acknowledgement of the information and instructions outlined in this Urgent Safety Advisory Notice. By signing this document, you are acknowledging that you have read and understand the content therein. .
- Root cause
- Software design
- Status
- Terminated
- Product code
- DQK
- Quantity affected
- 99 units
- Distribution
- US Nationwide distribution.
- Date initiated
- 2021-03-04
- Date posted
- 2021-04-19
- Date terminated
- 2024-09-30
- Location
- Malvern, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Sensis (K150493) | Siemens Medi Cal Solutions, Inc. | 2015-06-30 |