FDA recall Z-1425-2022

Siemens Medical Solutions USA, Inc · Class II · device

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

Reason for recall

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.

Distribution

US Nationwide Distribution AZ FL KY MI OH PR TX

Key facts

Status: Ongoing
Initiation date: 2022-06-15
Report date: 2022-07-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Malvern, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1425-2022