Medical Device Recall: 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 e
Siemens Medical Solutions USA, Inc · July 3, 2024
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.
Product Description
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
Distribution
US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
States Affected
NATIONWIDE
Quantity Affected
3 systems
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2438-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.