DIAGNOSTIC ULTRASOUND SYSTEM TUS-AI700Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04987670102509), received between Oct 4, 2021 and Oct 4, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Display or Visual Feedback Problem” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

2 other recalls cover devices cleared under the same FDA submission (K161843, K163702, K182679, K201972, K241582, K242808, K252074); 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. Sep 29, 2022Class IIOpen, Classified

   After completion, ultrasound system's Stress Echo may not terminate if user does not manually terminate the protocol. During next patient exam, an abnormal confirmation message will be displayed "Same view was saved in this phase. Do you use this image with StressEcho Review?" If "no", acquired images not saved, and if "yes" images assigned to the previous patient; could cause treatment delay.

   Z-0198-2023 · Root cause: Software Design Change · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 4, 2021Display or Visual Feedback Problem; Display or Visual Feedback Problem

  DURING A PERICARDIOCENTESIS PROCEDURE AT PHELPS COUNTY REGIONAL MEDICAL CENTER ON (B)(6) 2021, IT WAS REPORTED THAT PSI-30BX TRANSDUCER STARTED TO MALFUNCTION AND EVENTUALLY THE ULTRASOUND SYSTEM BECAME UNRESPONSIVE. THE STAFF PERFORMED A HARD SHUT DOWN, RESULTING IN THE SUBSEQUENT BOOT UP TO TAKE OVER 4 MINUTES TO COMPLETE. DURING THIS TIME, PATIENT WAS STILL IN CRITICAL STAGE WITH THE NEEDLE STILL INSERTED IN THEIR CHEST CAVITY. AFTER THE BOOTUP COMPLETED, THE CUSTOMER WAS ABLE TO CONTINUE WITH THE PROCEDURE SUCCESSFULLY WITH NO PATIENT INJURY OCCURRING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12569068 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K161843, K163702, K182679, K201972, K241582, K242808, K252074. One submission often covers many models, so check the product and lot details in each record.

• Z-2315-2018 · Jan 4, 2018 · Terminated
  Diagnostic Ultrasound System, Aplio I-series. Labeled as i700, i800, i900 The power supply unit may be damaged and may fail to start up when the power plug is inserted into a pow
• Z-2712-2017 · May 1, 2017 · Terminated
  APLIO i-series: a) APLIO i700 TUS AI700 b) APLIO i800 TUS AI800 diagnostic ultrasound system