Recall-Communication Disconnect Resulting in No Vital Signs Reported

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.

About the author

Allison joined SoftwareCPR in 2022, bringing along over ten years of passion for building teamwork and growth in organizations. This is established in part by the greatest University the South has to offer- Mississippi State.

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