ACUSON Sequoia Diagnostic Ultrasound System 11148775Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04056869173566), received between Mar 16, 2022 and Feb 18, 2026 — classified as 1 death, 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Application Program Freezes or Fails to Launch” (2 reports).

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2026Appropriate Device Problem Term/Code Not Available

  ON THE DAILY WORK PREPARATIONS PROCESS, THE CUSTOMER SUDDENLY DISCOVERED THICK SMOKE AND FLAMES EMANATING FROM THE REAR OF THE EQUIPMENT. AFTER AN IMMEDIATE CUTTING OFF THE POWER SUPPLY AND INSPECTION, THE CUSTOMER FOUND OBVIOUS BURN MARKS ON THE CABLES AT THE DP INTERFACE OF THE INPUT/OUTPUT PORTS. FOLLOWING THE CUSTOMER'S REPORT OF THE INCIDENT, COMPANY CSE CONDUCTED AN ON-SITE INSPECTION AND CONFIRMED THAT THE DP VIDEO OUTPUT CABLE HAD SIGNIFICANT BURN MARKS AT THE INTERFACE, RENDERING THE EQUIPMENT UNABLE TO POWER ON. ASIDE FROM THE EQUIPMENT ITSELF, THERE WAS NO OTHER PERSONAL INJURY OR PROPERTY DAMAGE. COMPANY HAS URGENTLY COORDINATED WITH SALES PARTNER TO PROCURE A DEMO UNIT OF THE SAME MODEL FOR THE CUSTOMER'S USE. THE COMPANY HAS HAD PRELIMINARY DISCUSSIONS WITH THE CUSTOMER REGARDING THE AFTERMATH. THE DAMAGED EQUIPMENT WILL BE RETURNED TO THE COMPANY FOR FURTHER TECHNICAL EVALUATION. THE CUSTOMER'S DAILY WORK HAS NOT BEEN AFFECTED IN ANY OTHER WAY.

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

  MAUDE report 24376636 ↗
• DeathJun 16, 2025Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem; Use of Incorrect Control/Treatment Settings; Adverse Event Without Identified Device or Use Problem

  ON 12-JUN-2025, THE DESIGNATED COMPLAINT UNIT (DCU) RECEIVED A COMPLAINT (B)(4). PER THE SUBMITTER, ON 10-JUN-2025, A PATIENT SENT A LETTER TO THE CUSTOMER ADMINISTRATION (B)(6), STRATHPINE, AUSTRALIA REGARDING "USE OF A THERMAL INDEX FOR CRANIAL BONE (TIC) VALUE OF 3.03 AND 3.16 DURING TWO EARLY PREGNANCY ULTRASOUNDS". THE LETTER STATED THAT THE PATIENT HAD UNDERGONE TWO EARLY PREGNANCY ULTRASOUNDS, PERFORMED ON (B)(6) 2025 AND (B)(6) 2025 AT THE SITE USING THE ACUSON SEQUOIA SYSTEM WITH A THERMAL INDEX FOR CRANIAL BONE (TIC) VALUE OF 3.03 AND 3.16, RESPECTIVELY. THEN ON (B)(6) 2025, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT AT (B)(6) HOSPITAL DUE TO BROWN DISCHARGE. AN ULTRASOUND WAS PERFORMED AT THE EMERGENCY ROOM, AND IT WAS FOUND THAT THE BABY HAD NO HEARTBEAT, AND ITS GROWTH CORRESPONDED TO 8 WEEKS AND 3/4 DAYS. THE PATIENT FURTHER ADDED THAT 2ND ULTRASOUND ON (B)(6) 2025 WITH (B)(6) HAD SHOWN A STRONG HEARTBEAT OF 130BPM WITH 8 WEEKS 4 DAYS GROWTH WHICH CONFIRMS THAT THE BABY DIED IN THE HOURS FOLLOWING THE ULTRASOUND.THE PATIENT STATES THAT DURING BOTH HER ULTRASOUND SCANS AT (B)(6) WERE PERFORMED AT THERMAL INDEX FOR CRANIAL BONE (TIC) VALUE OF 3.03 AND 3.16. PE

  Patient problems: Fetal Distress

  MAUDE report 22216253 ↗
• MalfunctionJun 6, 2025Overheating of Device; Overheating of Device

  A CUSTOMER COMPLAINT WAS FILED AT THE USER FACILITY BY A PATIENT THAT WAS THERE ON MAY 24 2025 CLAIMING THEY WERE BURNED BY THE 5C1 PROBE DURING THEIR TRANS-ABDOMINAL PELVIC EXAM.

  Patient problems: Skin Burning Sensation

  MAUDE report 22159445 ↗
• MalfunctionApr 2, 2025No Apparent Adverse Event; No Apparent Adverse Event

  THIS COMPLAINT TICKET IS BEING MIGRATED FROM GSMS (PM00379059, DATE COMPLAINT CREATED: 06/10/2024) TO SMARTSOLVE AS A PART OF THE GSMS SUNSET PROJECT (GSMS SHUTS DOWN ON 01-OCT-2024). THE INVESTIGATION WILL BE COMPLETED AND DOCUMENTED IN THE SMARTSOLVE COMPLAINT TICKET. MISSING IMAGES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750839 ↗
• MalfunctionApr 2, 2025Loss of Data; Loss of Data

  COPIED FROM (B)(4). NO IMAGES FOUND IN STUDY AFTER CLOSING IT LOCALLY. SYSTEM WOULD HAVE STORED A STUDY QUERIED FROM MWL SERVER AS "UNBEKANNT" (UNKNOWN).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21750833 ↗
• InjuryFeb 3, 2025Sharp Edges; Sharp Edges

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: THERE WAS A SHARP SURFACE ON THE CP HANDLE. WHEN THE SONOGRAPHERS GRASP THE CONTROL PANEL HANDLE WITH THEIR THUMBS UNDER, SOMETHING SCRATCHES THEIR THUMBS OR THEIR HANDS.

  Patient problems: Skin Tears

  MAUDE report 21292419 ↗
• MalfunctionFeb 3, 2025Human-Device Interface Problem; Human-Device Interface Problem

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: THE SONOGRAPHER MAINTAINS THAT THE CINE CLIP BUTTON WAS REPEATEDLY USED DURING A HIGH-RISK OB EXAM. WHEN THE SYSTEM WAS BROUGHT BACK TO THE DEPARTMENT, THEY COULD NOT BE VIEWED ON THE SYSTEM OR ON THE PACS SYSTEM. IT IS UNKNOWN IF THE CINE-CLIP THUMBNAILS WERE NOTED ON THE SIDE OF THE MONITOR DURING THE STUDY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21292199 ↗
• InjuryFeb 3, 2025Sharp Edges; Sharp Edges

  THIS REPORT IS BEING SUBMITTED FOLLOWING A RETROSPECTIVE REVIEW PERFORMED BY SIEMENS ULTRASOUND. IN THIS CASE: UNDER THE CONTROL PANEL THE SONOGRAPHER "CUT HER HAND" ON A PIECE OF METAL.

  Patient problems: Skin Tears

  MAUDE report 21290763 ↗
• MalfunctionJul 16, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  SYSTEM CRASHED DURING EXAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19754589 ↗
• MalfunctionJul 12, 2024Application Program Freezes or Fails to Launch; Application Program Freezes or Fails to Launch

  SYSTEM CRASHED DURING EXAM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19736166 ↗
• MalfunctionMar 16, 2022Operating System Becomes Nonfunctional

  THE TOUCHSCREEN OF THE ACUSON SEQUOIA ULTRASOUND SYSTEM FROZE DURING AN EXAM, AND HEALTH CARE PROVIDER WAS UNABLE TO USE THE MACHINE UNTIL A MANUAL RESTART WAS COMPLETED. THIS INCIDENT CAUSED A DELAY IN PATIENT CARE.

  Patient problems: Insufficient Information

  MAUDE report 13782108 ↗