Company: Stryker Instruments Div. of Stryker Corporation
Date of Enforcement Report: 7/21/2022
Class II

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

Recall Number: Z-1452-2022

REASON

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.

RECALLING FIRM/MANUFACTURER

Stryker Instruments Div. of Stryker Corporation

VOLUME OF PRODUCT IN COMMERCE

44 units

DISTRIBUTION

The products were distributed to the following US states: KS and ME.