Sensis 10764561Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 04056869010137), received between Oct 20, 2020 and Aug 19, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device Sensing Problem” (2 reports).

5 FDA recall records name this device's identifier, 4 still open.

6 other recalls cover devices cleared under the same FDA submission (K131812, K150493); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Nov 16, 2022Open, Classified

   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;

   Z-0775-2023 · Root cause: Software design · FDA record ↗

2. Jul 12, 2022Terminated

   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

   Z-1558-2022 · Root cause: Device Design · FDA record ↗

3. Jun 15, 2022Open, Classified

   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.

   Z-1425-2022 · Root cause: Device Design · FDA record ↗

4. Apr 13, 2022Open, Classified

   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.

   Z-1243-2022 · Root cause: Software Design Change · FDA record ↗

5. Nov 23, 2021Open, Classified

   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.

   Z-0499-2022 · Root cause: Software design · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Device Sensing Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50324740 ↗
• MalfunctionMar 17, 2026Display or Visual Feedback Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE SENSIS SYSTEM. DURING A PATIENT PROCEDURE, THE DEVICE DISPLAYED AN INCORRECT SPO2 VALUE. THE DEVICE SHOWED THE SP02 READING AT 100% WHILE THE PATIENT SKIN TURNED BLUISH. DETAILED INVESTIGATION INTO WHETHER, AND TO WHAT EXTENT, THE SYSTEM CONTRIBUTED TO THIS CONDITION IS CURRENTLY ONGOING. THE PROCEDURE WAS CONTINUED ON AN ALTERNATE SYSTEM.

  Patient problems: Cyanosis

  MAUDE report 24616158 ↗
• MalfunctionNov 7, 2021No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED A PROBLEM WITH THE WAVEFORMS. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12758594 ↗
• MalfunctionJul 30, 2021Activation Failure; Activation Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHEN USING THE SENSIS SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE SYSTEM HAD NO CONNECTION TO THE INTEGRATED SIGNAL INPUT BOX (ACTIVATION FAILURE). THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. SIEMENS HAS NOT BEEN MADE AWARE OF ANY ADVERSE HEALTH EFFECTS TO THE INVOLVED PATIENT. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12255852 ↗
• MalfunctionApr 30, 2021Device Sensing Problem; Device Sensing Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT THEY WERE UNABLE TO DETECT PRESSURES. THE PROCEDURE WAS CONTINUED AND COMPLETED ON AN ALTERNATE SYSTEM. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11752554 ↗
• MalfunctionNov 30, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED TO SIEMENS THAT DURING A SCHEDULE DIAGNOSTIC PROCEDURE ON THE SENSIS UNIT THE USER WAS UNABLE TO BALANCE THE PRESSURES. THE USER MADE SEVERAL ATTEMPTS TO BALANCE THE PRESSURES UNSUCCESSFULLY, AND THE PATIENT HAD TO BE MOVED TO ANOTHER ROOM TO COMPLETE THE EXAM ON ALTERNATE SYSTEM. AT THIS TIME, SIEMENS HAS NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10924575 ↗
• MalfunctionNov 25, 2020Radiation Output Problem; Radiation Output Failure; Radiation Output Problem; Radiation Output Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE AXIOM SENSIS SYSTEM. DURING A PATIENT PROCEDURE, THE USER REPORTED A SIGNAL ACQUISITION ERROR. THE PATIENT WAS TRANSFERRED TO AN ALTERNATE DEVICE TO COMPLETE THE PROCEDURE. THERE ARE NO INJURIES ATTRIBUTED TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10905684 ↗
• InjuryOct 20, 2020Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION AND SUBSEQUENT ADVERSE EVENT OCCURRED WHILE OPERATING THE SENSIS SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE SPO2 VALUE DISPLAYED WAS QUESTIONABLE. IT WAS REPORTED THAT THE PATIENT REQUIRED RESUSCITATION. FOLLOWING RESUSCITATION WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 10705284 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K131812, K150493. One submission often covers many models, so check the product and lot details in each record.

• Z-1426-2022 · Jun 15, 2022 · Open, Classified
  Sensis Vibe Combo with software version VD12A. A diagnostic and administrative tool supporting hemodynamic catheterizations and/or electrophysiology studies, for cardiac as well a
• Z-0226-2022 · Oct 5, 2021 · Open, Classified
  Sensis/ Sensis Vibe systems with software VD1X as follows: (1)Sensis Model 10764561 (2) Sensis Vibe Hemo Model 11007641 (3)Sensis Vibe Combo Model 11007642 Intended Use: A diag
• Z-1434-2021 · Mar 4, 2021 · Terminated
  Sensis/ Sensis Vibe Hemo systems with VD12A software as follows: Dedicated SIS Server- 6648153 Sensis Post-Processing Workstation- 6648161 Sensis- 10764561 VM Virtual Server-
• Z-1173-2021 · Jan 27, 2021 · Terminated
  Sensis / Sensis Vibe systems with software version VD12 and equipped with HP Flex Pro-C PC. Diagnostic and administrative tool supporting hemodynamic catheterizations and/or elect
• Z-2921-2020 · Jul 24, 2020 · Terminated
  Siemens Sensis Vibe Hemo system in combination with the MicroPodTM EtCO2 module-diagnostic and administrative tool supporting hemodynamic catheterization and/or electrophysiology
• Z-0936-2019 · Nov 29, 2018 · Terminated
  Sensis Vibe System, Model Number 11007642, with software version VD10B.