The Recall Desk

FDA (Devices) recall action 90504

Siemens Medical Solutions USA, Inc recalled 2 products on 2022-07-27

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2022-07-27
Critical
0
Units
15

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2022-07-27

    Sensis diagnostic tool software may fail to display vital signs

    Siemens' Sensis diagnostic tool may lose communication and fail to display vital signs during initial patient exams or after inactivity. Software updates are required.

    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
    Category
    Distribution
    7 states
  • HighFDA (Devices)··2022-07-27

    Sensis Vibe Combo Device Recalled for Software Communication Failure

    The Sensis Vibe Combo diagnostic system may experience communication failure during patient procedures, causing vital signs data to be unavailable. The recall affects 13 units distributed across multiple U.S. states.

    Product
    Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well as interventional Radiology Model: 11007642
    Category
    Distribution
    7 states