ACUSON SC2000 Diagnostic Ultrasound System 10433816Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04056869002804), received between Feb 3, 2025 and Apr 7, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Failure to Conduct” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K102017, K113179, K130754, K132654, K141846, K142395, K162221, K170315, K181098, K202683, K211726, K233613); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Appropriate Device Problem Term/Code Not Available

  THE IMAGE QUALITY IS NOT SHARP, DELAY IN RESPONSE WHEN PUSHING THE BUTTONS SPECIFICALLY WITH STRESS, DGC NOT REACTING TO SLIDER POSITION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24801242 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  SYSTEM IS BOOTING TO A WINDOWS BLUE SCREEN CONSISTENTLY. PROBLEM STARTED YESTERDAY, AS THE SYSTEM IS USED FOR PORTABLE EXAMS AND A PATIENT STUDY WAS LOST AND COULD NOT BE FOUND. IT GOES THROUGH THE INITIAL SEQUENCE OF THE SPLASH SCREEN AND PROGRESS BAR BUT DISPLAYS MULTIPLE DOS WINDOWS AND TURNS INTO A WINDOWS BLUE SCREEN. IT WASN'T NOTED WHAT TEXT WAS DISPLAYED.

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

  MAUDE report 24376639 ↗
• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  THE DEVICE SUDDENLY LOST POWER AND WILL NOT START UP. * TURNING THE DEVICE'S BREAKER OFF AND ON DID NOT IMPROVE THE SITUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376630 ↗
• MalfunctionOct 29, 2025Failure to Conduct; Failure to Conduct

  THE CUSTOMER REPORTED THAT WHEN CONNECTING THE Z6MS PROBE, THE DEVICE DISPLAYS THE ERROR USACQUISITIONHW_31 AND THE SYSTEM REQUESTS THE REMOVAL OF THE PROBE. THE ISSUE IS THERMAL IN NATURE AND OCCURS EVERY TIME THE PROBE IS CONNECTED. WHEN CONNECTING V5M TEE PROBES, THE ERROR DOES NOT OCCUR. THIS OCCURRED DURING AN EXAM AND THE PHYSICIAN INTERRUPTED THE EXAM BY SHUTTING DOWN THE EQUIPMENT AND REMOVING THE TRANSDUCER FROM THE PATIENT. THE EXAM WAS COMPLETED WITH A REGULAR (NON-4D) TEE TRANSDUCER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23417224 ↗
• MalfunctionOct 12, 2025Failure to Conduct; Failure to Conduct

  ERROR MESSAGE DURING Z6M EXAM: USACQUISTIONHW_31. THE EXAM WAS CANCELED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23273933 ↗
• MalfunctionOct 12, 2025Positioning Failure; Positioning Failure

  DURING A CARDIAC EXAM, THE Z6MS TRANSDUCER IMAGE COULD NOT BE ADJUSTED. THE ANGLE COULD NOT BE FIXED WHEN LOOKING AT THE IMAGE AND IT RETURNED 0. THERE WAS NO PATIENT INJURY AND ANOTHER SYSTEM WAS USED TO COMPLETE THE EXAM

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23273902 ↗
• MalfunctionJul 1, 2025Failure to Conduct; Failure to Conduct

  ERROR CODE USACQUISTIONHW_40_0 WHEN USING Z6MS TRANSDUCER. THIS OCCURRED DURING A TEE EXAM AND ANOTHER SYSTEM WAS USED TO COMPLETE THE EXAM. THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368619 ↗
• MalfunctionMay 19, 2025Poor Quality Image; Poor Quality Image

  THE IMAGE QUALITY WAS POOR WHEN USING THE Z6MS TRANSDUCER. THE EXAM WAS STOPPED AS A RESULT AND THE PATIENT WAS RESCHEDULED FOR THE NEXT DAY. THERE WERE NO INJURIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22042502 ↗
• MalfunctionMar 16, 2025Failure to Conduct; Failure to Conduct

  Z6MS (SN: (B)(6)) PROBE ERROR USACQUISITIONHW_31 OCCURS EVERY TIME WHEN THE PROBE IS CONNECTED. THIS OCCURRED DURING A VALVE REPLACEMENT. THE CUSTOMER TOOK OUT THE TRANSDUCER FROM THE PATIENT'S ESOPHAGUS AND REPLACED WITH A DIFFERENT TEE TRANSDUCER AND SYSTEM (OF A DIFFERENT COMPANY). THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21615302 ↗
• MalfunctionFeb 3, 2025Positioning Failure; Positioning Failure

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: Z6MS: BOTTOM KNOB ON CONTROL HOUSING SPINNING FREELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292481 ↗
• MalfunctionFeb 3, 2025Computer Software Problem; Computer Software Problem

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: CUSTOMER COMPLAINING OF SYSTEM LOCKUP DURING PROCEDURE AT APPROXIMATELY 1300 ON (B)(6) 2023. NO SERIOUS OR MINOR INJURIES WERE REPORTED. THE PROCEDURE WAS DELAYED AND SYSTEM HAD TO BE SWITCHED OUT FOR ANOTHER UNIT TO CONTINUE PROCEDURE. LOGS WERE ESCALATED TO RSC/HSC. C: DRIVE INDICATED FULL..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292268 ↗
• MalfunctionFeb 3, 2025Poor Quality Image; Poor Quality Image

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: POOR 2D , COLOUR AND 3D IMAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21291868 ↗
• MalfunctionFeb 3, 2025No Display/Image; No Display/Image

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: BLANK SCREEN DURING AN ICE EXAM AND THE ACUNAV PROBE WAS NOT BEING. RECOGNIZED. ALL PORTS WERE TRIED AND THE ACUNAV PROBE WAS BEING. RECOGNIZED. THIS OCCURED TODAY TUESDAY (B)(6) 2023, AROUND 0800 LOCAL. TIME. THE CUSTOMER USED ANOTHER SYSTEM TO COMPLETE THE EXAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290856 ↗
• MalfunctionFeb 3, 2025Power Problem; Power Problem

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: SYSTEM SHUT DOWN BY ITSELF DURING A TEE EXAM WITH A SEDATED PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21290773 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102017, K113179, K130754, K132654, K141846, K142395, K162221, K170315, K181098, K202683, K211726, K233613. One submission often covers many models, so check the product and lot details in each record.

• Z-1200-2018 · Mar 5, 2018 · Terminated
  ACUSON SC2000 Ultrasound System. The firm name on the label is Siemens Medical Solutions USA, Inc., Buffalo Grove, IL.
• Z-1065-2018 · Jan 26, 2018 · Terminated
  ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Tr
• Z-1907-2011 · Feb 4, 2011 · Terminated
  8V3c transducer used with the ACUSON SC2000 ultrasound system. 8V3c transducer model number 10433823; ACUSON SC2000 model number 10433816. Siemens Medical Solutions USA, Inc. Bus