Recall Z-1425-2022
Siemens Medical Solutions USA, Inc · initiated June 15, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sensis with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model:10764561
Codes / lots: UDI-DI: 04056869010137 Serial Numbers: 61331, 60015
Reason for recall
Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the first patient examination of the day or after a longer period of inactivity to the Sensis Vibe system resulting in no vital signs being available.
FDA-determined cause: Device Design
Action taken
Siemens issued a Customer Safety Advisory Notice (AX016/22/S) dated 6/15/22 distributed to customers. Letter states reason for recall, health risk and action to take. The BIOS configuration of the ComboBox in the affected systems will be updated to correct the issue. This corrective action will be distributed via Update Instruction AX015/22/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
Details
- Recall number
- Z-1425-2022
- Initiated
- June 15, 2022
- Product code
- DQK – Computer, Diagnostic, Programmable
- Quantity
- 2 units
- Distribution
- US Nationwide Distribution AZ FL KY MI OH PR TX
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1426-2022 Class II | Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool…Sensis/Sensis Vibe SoftwareVD12A, the ComboBox may encounter a disconnect of its communication during the… | 06/15/2022Open, Classified |