ACUSON Juniper Diagnostic Ultrasound System 11335791Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04056869152059), received between Feb 5, 2025 and Aug 13, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

3 FDA recall records name this device's identifier, 2 still open.

1 other recall cover devices cleared under the same FDA submission (K180039, K201130, K221190, K230207, K253457); 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.

Recalls naming this device

1. Aug 15, 2024Class IIOpen, Classified

   If ultrasound systems with software, are changed from factory default to : 1) Milliliters per second (ml/sec, mL/sec) or 2) Milliliters per minute (ml/min, mL/min); then systems will perform incorrect unit conversion of liters to milliliters using multiplier 100 instead of 1000, resulting values 10x smaller than actual, which could contribute misdiagnosis or negatively influence patient management

   Z-3215-2024 · Root cause: Software design · Recall details · FDA record ↗

2. Feb 23, 2024Class IIOpen, Classified

   On ultrasound systems, when Cardiac DICOM SR feature is configured to display either minimum or maximum measured value, and multiple cardiac region measurements are made, and results are exported into the SR feature, then The SR viewer will display the LAST measured value, not min or max, which could contribute to patient condition misdiagnosis or negatively influence patient management decisions.

   Z-1599-2024 · Root cause: Software design · Recall details · FDA record ↗

3. Jul 12, 2021Class IITerminated

   Due to intermittent failures of the power supply in the ultrasound system which renders it inoperable.

   Z-2471-2021 · Root cause: Software change control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THERE WAS A SYMPTOM THAT THE TEST WAS AUTOMATICALLY TERMINATED DURING THE PATIENT TEST THIS MORNING. (END EXAM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22796979 ↗
• MalfunctionFeb 5, 2025Loss of Data; Loss of Data

  THERE WAS A SYMPTOM THAT THE TEST WAS AUTOMATICALLY TERMINATED DURING THE PATIENT TEST THIS MORNING. (END EXAM). 2) THE PATIENT DATA SAVED BEFORE WAS NOT SAVED, AND WE HAD NO CHOICE BUT TO CALL THE PATIENT BACK AND PROCEED WITH THE EXAMINATION AGAIN. 3) THIS SYMPTOM OCCURRED A WEEK AGO AS WELL, AND 2 CASES OCCURRED AFTER UI UPDATE WITH VB10D. 4) THE IMAGES TAKEN BEFORE THE START OF THE TEST REMAIN AFTER THE PATIENT IS CALLED TO THE WORKLIST, AND THE DATA TAKEN AFTER THE START OF THE TEST ARE NOT SAVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315715 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K180039, K201130, K221190, K230207, K253457. One submission often covers many models, so check the product and lot details in each record.

• Z-0748-2022 · Jan 19, 2022 · Open, Classified
  Diagnostic Ultrasound System, ACUSON Juniper, UDI: (01)04056869152059, Model: 11335791, Rx, CE Ultrasound imaging system intended for the following applications: Vascular, Abdom