FDAFDA · Food and drugs·Recall number Z-1425-2022
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
Published July 27, 2022 · Recall initiated: June 15, 2022
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
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Siemens Medical Solutions USA, Inc
- Distributor
- US Nationwide Distribution AZ FL KY MI OH PR TX
- Lot
- UDI-DI: 04056869010137 Serial Numbers: 61331, 60015
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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