Sensis

• • Ongoing Z-0775-2023 FDA Class II ·initiated 16 Nov 2022

  The firm will be performing a software update to address a software error which affects the listed products. This correction addresses four potential software issues: 1) "PASSWORD STORE CORRUPTED" error message during system boot; 2) Subsystem crash during examination; 3) Dialog Monitor Computer (DMC) application crash while loading a study; and 4) Software crash due to system internal timeout. Issue 1 may lead to a delay or interruption of procedure. Issues 2, 3, and 4 may result in delay in starting or continuing the examination, and may also prevent the operator from starting or continuing a study;

• 2 recalls, same reason

  • Ongoing Z-1426-2022 FDA Class II ·initiated 15 Jun 2022
  • Ongoing Z-1425-2022 FDA Class II ·initiated 15 Jun 2022

  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.

• • Ongoing Z-1243-2022 FDA Class II ·initiated 13 Apr 2022

  Siemens has become aware of three potential software issues with AXIOM Sensis or Sensis/ Sensis Lite systems. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and treatment needs to be continued on an alternate system.

• • Ongoing Z-0499-2022 FDA Class II ·initiated 23 Nov 2021

  Software error which affects Sensis Vibe Hemo, Sensis and Sensis Vibe Combo systems with software version VD12A, which could cause possible hazard to patients, operators, or other persons and equipment. Under certain sporadic circumstances, the CO (Cardiac Output) measurement using the Thermodilution method will temporarily no longer be possible.

• • Ongoing Z-0226-2022 FDA Class II ·initiated 5 Oct 2021 ·on shared 510(k) K150493

  System operator manual states that the system should be rebooted once, every 7 days. In some cases, users are not following these instructions and the system is running for more than 7 days. Under rare circumstances, this may result in a partial freeze of the user interface which would no longer update the vital signs

• • Terminated Z-1558-2022 FDA Class III ·initiated 12 Jul 2022

  The Sensis Signal Input Box provides hooks as a milled item on the bottom of the box support the possibility of mounting the Signal Input Box on an accessory rail (e.g., at the patient table), In the event the mounting position deviates from the default position, the following are possible: Patient touching the Signal Input Box may result in a touch leakage current to the patient; Spillage of liquid entering the Signal Input Box

• • Terminated Z-1434-2021 FDA Class II ·initiated 4 Mar 2021

  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

• • Terminated Z-1173-2021 FDA Class II ·initiated 27 Jan 2021

  System may sporadically freeze (lock-up) during operation or while being in an idle state, no longer possible to interact with the system

• • Terminated Z-2921-2020 FDA Class II ·initiated 24 Jul 2020

  The connector linking the EtCO2 module to the HemoBox may break and become damaged, if the connector is re-attached to the HemoBox in this damaged state, under certain incorrect pin alignment conditions, the HemoBox may stop functioning and all vital signs are lost

• • Terminated Z-0936-2019 FDA Class II ·initiated 29 Nov 2018

  A software error may result in a system crash. The system must be restarted before the clinical procedure can be continued. The ablation treatment must be performed with a different system or without the use of the interface.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K150493 ↗

FDA Product Code

DQK

Device Class

Class II

Regulation

21 CFR Part 870.1425

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Syngo.CT Vascular Analysis

  Class II

  FDA 510(k) K112020 Active Cleared 18 Aug 2011

• Acuson SC2000 Diagnostic Ultrasound System

  Class II

  FDA 510(k) K142628 Active Cleared 10 Oct 2014

• Syngo.VIA

  Class II

  FDA 510(k) K123920 Active Cleared 18 Jan 2013

• Syngo.plaza

  Class II

  FDA 510(k) K093612 Active Cleared 4 Mar 2010

• Syngo Dynamics Version 7.0

  Class II

  FDA 510(k) K081018 Active Cleared 25 Apr 2008

• MOBILETT Impact

  Class II

  FDA 510(k) K231577 Active Cleared 25 Jul 2023

See all devices from Siemens Medi Cal Solutions, Inc. →

• What is the Sensis used for?

  The Sensis is used in cardiovascular applications, specifically as a cardiac pacemaker.

• Is the Sensis a single-use or reusable device?

  The Sensis is a reusable device, but specific storage and handling instructions are not provided.

• What is the regulatory status of the Sensis?

  The Sensis has been cleared under the FDA 510(k) process, with a K-number of K150493, indicating substantial equivalence to other devices in its class.