Company: Siemens Medical Solutions USA, Inc
Date of Enforcement Report: 4/28/2021
Class II

PRODUCT

Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server- 10765502 Sensis High-End Servers- 10910620 Sensis Vibe Hemo- 11007641 Sensis Vibe Combo- 11007642 Sensis Vibe is a recording and procedure data management system for interventional cardiology, interventional radiology, surgical procedures performed in a hybrid OR and electrophysiology.

Recall Number: Z-1434-2021

REASON

Due to the configuration of certain Windows Service Permissions within the operating systems of the Sensis/ Sensis Vibe computer, there is a risk for exposure of sensitive information, manipulation of data, or Denial of Service attacks and could result in incorrect diagnostic or therapeutic decisions.

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions USA, Inc on 3/4/2021. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

88 units

DISTRIBUTION

U.S. Nationwide