FDAFDA · Food and drugs·Recall number Z-2441-2024
Sensis Vibe systems with software version VD15B-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: 11007641
Published July 31, 2024 · Recall initiated: July 3, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide distribution in the states of CA, CT, FL, IA, KS, MA, MI, NJ, TX, VA.
- Lot
- UDI-DI: 4056869010199 Serial Numbers: 18009 18010 18011 18014 18015 18016 19001 103584 103596 104064 106244 106245 ***Update 7/24/24*** S/N Added: 102183
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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