Recall Z-2438-2024
Siemens Medical Solutions USA, Inc · initiated July 3, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Sensis Vibe systems with software version VD15B in combination with Sensis High End Server -Intended to be used as a diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology as well as surgical studies. Equipped by modules, enabling various configurations. Model: 10910620
Codes / lots: UDI-DI: N/A Serial Numbers: 15000 15001 15003
Reason for recall
If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.
FDA-determined cause: Software design
Action taken
Siemens issued Urgent Medical Deice Correction letter (AX038/23/S-C) on 7/3/24 to Director of Diagnostic Imaging and/or Radiology Laboratory. Letter states reason for recall, health risk and action to take: If the Sensis documentation functionality is used and the described scenario occurs, users should continue the exam by opening a new study for the same patient without adding any Type 1 reporting events. You can compensate this by adding free text comments (procedure notes) only and manually inserting the desired information in those comments. Please ensure that patient treatment can be continued in other ways if there is any possible danger for the safety of the patient. How will the corrective action be implemented and what is the efficiency of the corrective actions? Siemens will correct the error with a software update via Update Instruction AX010/23/S. The corrective action mitigates the probability of occurrence of the issue. Based on our investigation you can continue to use your system/device. 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 Customer Safety Advisory Notice. Please respond within 14 days of receiving this notification. If you have received this notification by email via Adobe GigaSign, kindly sign with your digital signature to acknowledge that you have read and understand the content provided. If you have received this customer notification by delivery by the US Postal Service or by FedEx, please send an email to recallsandrefusals.team@siemens-healthineers.com acknowledging that you have read and understand the content provided
Details
- Recall number
- Z-2438-2024
- Initiated
- July 3, 2024
- Posted by FDA
- July 25, 2024
- Product code
- DQK – Computer, Diagnostic, Programmable
- Quantity
- 3 systems
- Distribution
- US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
- Recalling firm
- Siemens Medical Solutions USA, Inc, Malvern, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2439-2024 Class II | Sensis Vibe systems with software version VD15B in combination with VM VIRTUAL SERVER…If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g.… | 07/03/2024Open, Classified |
| Z-2440-2024 Class II | Sensis Vibe systems with software version VD15B in combination with AXIOM Sensis Post…If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g.… | 07/03/2024Open, Classified |
| Z-2441-2024 Class II | Sensis Vibe systems with software version VD15B-Intended to be used as a diagnostic and…If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g.… | 07/03/2024Open, Classified |