Sensis Vibe Hemo 11007641Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04056869010199), received between Jul 17, 2020 and Jan 23, 2026 — classified as 1 death, 21 malfunctions.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (3 reports).

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

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jul 3, 2024Class IIOpen, Classified

   If the Sensis documentation functionality is used during adding of once-per-study reporting events (e.g., Type 1 events, as further defined in the administrator manual), the possibility exists that the application could crash.

   Z-2441-2024 · Root cause: Software design · Recall details · FDA record ↗

2. Nov 29, 2023Class IIOpen, Classified

   The possibility of the Sensis documentation functionality application to crash.

   Z-0683-2024 · Root cause: Software design · Recall details · FDA record ↗

3. Nov 16, 2022Class IIOpen, 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 · Recall details · FDA record ↗

4. Nov 23, 2021Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 23, 2026Computer Software Problem

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN EMERGENCY PATIENT PROCEDURE, A MESSAGE ABOUT A SOFTWARE UPDATE APPEARED ON THE SCREEN AND COULD NOT BE CLOSED BY THE USER. THE PATIENT HAD TO BE RELOCATED TO AN ALTERNATIVE SYSTEM TO COMPLETE THE PROCEDURE. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24161033 ↗
• MalfunctionMar 25, 2025Unable to Obtain Readings; Unable to Obtain Readings

  IT WAS REPORTED TO SIEMENS HEALTHINEERS THAT A MALFUNCTION OCCURRED WHILE USING THE SENSIS VIBE HEMO. DURING AN EMERGENCY PROCEDURE, THE USER STATED THAT THERE WAS NO ECG MONITORING AVAILABLE DURING THE PROCEDURE. THE PROCEDURE WAS CONTINUED AND FINISHED USING AN ALTERNATE SYSTEM. WE HAVE NO INDICATION OF ANY ADVERSE EFFECTS ON THE STATE OF HEALTH OF THE PATIENT INVOLVED. SIEMENS HEALTHINEERS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO INVESTIGATE THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21686066 ↗
• MalfunctionJan 2, 2024Communication or Transmission Problem; No Visual Prompts/Feedback; Communication or Transmission Problem; No Visual Prompts/Feedback

  SIEMENS BECAME AWARE OF A MALFUNCTION WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN EMERGENCY PROCEDURE, THE SYSTEM FAILED TO DISPLAY VITAL SIGNS AND CURVES AS COMMUNICATION WITH HEMO INTEGRATED SIGNAL INPUT BOX (HISIB) WAS LOST. THE PATIENT HAD TO BE MOVED AND THE PROCEDURE WAS CONTINUED ON AN ALTERNATE UNIT. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18427525 ↗
• MalfunctionDec 4, 2023No Display/Image; No Device Output; No Display/Image; No Device Output

  SIEMENS BECAME AWARE OF A MALFUNCTION THAT OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. PRIOR TO AN EMERGENCY PATIENT PROCEDURE, THERE WAS NO DISPLAY OUTPUT. THE FAILURE CAUSED A LONG-TERM DELAY OF THE EMERGENCY PROCEDURE. WE HAVE NO INDICATIONS OF ANY ADVERSE EFFECTS ON THE HEALTH STATUS OF THE INVOLVED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18256642 ↗
• MalfunctionAug 22, 2023Incorrect Measurement; Incorrect Measurement

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING A PROCEDURE ON A PATIENT SUFFERING FROM A HEART ATTACK, NO AORTIC PRESSURE MEASUREMENT WAS AVAILABLE TO THE USER. WE ARE UNAWARE OF ANY ADVERSE IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594950 ↗
• MalfunctionJul 25, 2023Program or Algorithm Execution Problem; Program or Algorithm Execution Failure; Program or Algorithm Execution Problem; Program or Algorithm Execution Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED THAT EXAMINATION WAS NOT POSSIBLE AFTER PATIENT REGISTRATION. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388015 ↗
• MalfunctionApr 13, 2023Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. THE USER REPORTED THAT AFTER BOOTING THE SYSTEM, IT DISPLAYED A BLUE SCREEN INDICATING THAT WINDOWS NEEDED TO BE REPAIRED. THIS CAUSED A LONG TERM DELAY WHICH OCCURRED BEFORE AN EMERGENCY PROCEDURE. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730719 ↗
• MalfunctionApr 13, 2023Activation, Positioning or Separation Problem; Activation Failure; Activation, Positioning or Separation Problem; Activation Failure

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. THE USER REPORTED THAT AFTER BOOTING THE SYSTEM, IT DISPLAYED A BLUE SCREEN INDICATING THAT WINDOWS NEEDED TO BE REPAIRED. THIS CAUSED A LONG TERM DELAY WHICH OCCURRED BEFORE AN EMERGENCY PROCEDURE. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16730718 ↗
• MalfunctionDec 5, 2022Incorrect, Inadequate or Imprecise Result or Readings; Output Problem; Incorrect, Inadequate or Imprecise Result or Readings; Output Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. SIEMENS SERVICE ORGANIZATION REPORTED THAT THE CALCULATIONS OF THE CARDIAC OUTPUT VALUE WERE INCORRECT. ON NOVEMBER 21, 2022, SIEMENS RECEIVED INFORMATION THAT THE REPORTED ISSUE MAY HAD CAUSED FALSE PRESCRIPTION. HOWEVER, THIS INFORMATION HAS NOT BEEN CONFIRMED. 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 15915093 ↗
• DeathAug 3, 2022Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO SIEMENS THAT AN ADVERSE EVENT OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. THE USER REPORTED THAT THE P3 PRESSURE DRIFTED UP DURING THE PCI CASE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE PATIENT PASSED AWAY, HOWEVER, NO CAUSAL RELATIONSHIP WAS FOUND BETWEEN THE FAILURE AND THE DEATH OF THE PATIENT. SIEMENS HAS REQUESTED ADDITIONAL INFORMATION IN ORDER TO CONDUCT AN INVESTIGATION OF THE REPORTED EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 15156123 ↗
• MalfunctionMay 31, 2022Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN EMERGENCY PROCEDURE, THE USER REPORTED A SYSTEM BOOT PROBLEM. 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 14546227 ↗
• MalfunctionFeb 7, 2022No Display/Image; No Display/Image

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE ROOM WAS DOWN AND THE ETHERNET ADAPTER CABLE WAS DAMAGED. 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 13469855 ↗
• MalfunctionDec 22, 2021Unintended Application Program Shut Down; Unintended Application Program Shut Down

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE DEVICE WAS TOTALLY DOWN FOLLOWING SYSTEM REBOOT. 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. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13061197 ↗
• MalfunctionDec 20, 2021Failure to Sense; Failure to Sense

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE LIMB LEADS FLAT LINE WHEN THE V LEADS ARE CONNECTED. 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 13042120 ↗
• MalfunctionSep 8, 2021Patient Data Problem; Patient Data Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. THE USER REPORTED THAT THE ACQUIRED IMAGES FROM THE CURRENT PATIENT WERE STORED IN THE FOLDER OF THE LAST PATIENT COMPLETED THE DAY BEFORE. THERE IS NO REPORT OF IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER 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 12438926 ↗
• MalfunctionJul 19, 2021Electrical /Electronic Property Problem; Power Problem; Electrical /Electronic Property Problem; Power Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO LOW SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE UNINTERRUPTIBLE POWER SUPPLY (UPS) STARTED BEEPING UNTIL THE SENSIS VIBE HEMO STOPPED WORKING. 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. THE REPORTED EVENT OCCURRED IN (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188851 ↗
• MalfunctionMay 26, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING A PROCEDURE, THE USER REPORTED INTERMITTENTLY RECEIVING UNUSUAL ANALOG OUTPUT PRESSURE 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 11884487 ↗
• MalfunctionMay 5, 2021Patient Data Problem; Patient Data Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. THE USER REPORTED THAT PATIENT DATA FROM A PREVIOUS CASE WAS SHOWING IN THE MOST RECENT CASE ON THE PATIENT EXPLORER. AT THIS TIME, WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF ANY PATIENT OR USER 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 11775886 ↗
• MalfunctionApr 27, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING A PROCEDURE, THE USER REPORTED THAT NO ECG TRACING WAS BEING DISPLAYED. 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 11730823 ↗
• MalfunctionMar 17, 2021Application Program Problem; Application Program Problem

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT THE APPLICATION CRASHED. 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 11505882 ↗
• MalfunctionFeb 22, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED TO SIEMENS THAT A MALFUNCTION OCCURRED WHILE OPERATING THE SENSIS VIBE HEMO SYSTEM. DURING AN INTERVENTIONAL PROCEDURE, THE USER REPORTED THAT PRESSURE MEASUREMENT WAS NOT POSSIBLE. 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 11357507 ↗
• MalfunctionJul 17, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO SIEMENS THAT AN ERROR OCCURRED WHILE USING THE SENSIS VIBE HEMO SYSTEM. THE USER REPORTED THAT THE MICROPOD CONNECTOR HAS BENT PINS. WE ARE UNAWARE OF ANY IMPACT TO THE STATE OF HEALTH OF THE PATIENT INVOLVED. THE PRELIMINARY ROOT CAUSE ANALYSIS CARRIED OUT ON 2020-06-18 (NEW AWARENESS DATE) CONSIDERED A POTENTIAL HAZARDOUS SITUATION OF INCORRECT OR INSUFFICIENT BASIS FOR DIAGNOSTIC OR THERAPEUTIC DECISIONS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10289407 ↗