DIAGNOSTIC ULTRASOUND SYSTEMRecalls & reported problems across all models
Canon Inc. · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one DIAGNOSTIC ULTRASOUND SYSTEM model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 1
We found 5 models of DIAGNOSTIC ULTRASOUND SYSTEM by Canon Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, 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 at least one of these models by its device identifier, 1 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
DIAGNOSTIC ULTRASOUND SYSTEM recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Sep 29, 2022Open, 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 · names 5 of these models · Recall details · FDA record ↗
Most reported DIAGNOSTIC ULTRASOUND SYSTEM problems
Device problems
- Display or Visual Feedback Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
DIAGNOSTIC ULTRASOUND SYSTEM models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DIAGNOSTIC ULTRASOUND SYSTEM TUS-AI700System, imaging, pulsed echo, ultrasonic1 recall1 report
- DIAGNOSTIC ULTRASOUND SYSTEM TUS-AI800System, imaging, pulsed echo, ultrasonic1 recall0 reports
- DIAGNOSTIC ULTRASOUND SYSTEM TUS-AI900System, imaging, pulsed echo, ultrasonic1 recall0 reports
- DIAGNOSTIC ULTRASOUND SYSTEM CUS-AA450Transducer, ultrasonic, diagnostic1 recall0 reports
- DIAGNOSTIC ULTRASOUND SYSTEM CUS-AA550Transducer, ultrasonic, diagnostic1 recall0 reports
Recent DIAGNOSTIC ULTRASOUND SYSTEM adverse event reports
The 1 most recent reports across all models, 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 ↗
Other Canon Inc. products
All Canon Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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