Skip to content

DIAGNOSTIC ULTRASOUND SYSTEM recallZ-0198-2023 · Canon Medical System, USA, INC. · initiated Sep 29, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Canon Medical System, USA, INC. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Software Design Change

What the company is doing

On 9/29/22, correction notices were mailed to customers who were asked to do the following until the software corrective action had been implemented: Terminate Stress Echo by pressing "X" or "Quit" on the touch panel when completing the exam. If the exam is completed without terminating Stress Echo, and the confirmation message shown in section 2 is displayed when saving the first image in the next Stress Echo, terminate Stress Echo by pressing "X" or "Quit", and then start Stress Echo again. However, if the confirmation message is not displayed when saving the first image in Stress Echo, the function can be used normally. Share the contents of this letter with all users and reviewing radiologist as well as clinical engineering or biomedical group at your facility. Complete and return the response form. For software scheduling questions, please contact your respective Area Service Manager or our InTouch team at [email protected].

Recall details

Recall number
Z-0198-2023
Status
Open, Classified
Initiated by the company
Sep 29, 2022
Posted by the FDA
Nov 8, 2022
Recalling firm
Canon Medical System, USA, INC.
Quantity
65
Product code
IYN
FDA submissions
K212333, K212960
Distribution
US: MT, MO, NC, SC, MN, WA, KY, TN, AR, IL, IA, MI, WV, KS, CA, HA, CO, LA, OK, ME, KY, NY, PA, GA, FL

Product description

Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550 CUS-AA550, Aplio a450 CUS-AA450

Code information (models, lots, serial numbers)

Model/UDI-DI, with software: Aplio i900 TUS-AI900/ 04987670102523, Aplio i800 TUS-AI800/ 04987670102516, Aplio i700 TUS-AI700/ 04987670102509, With System Version:V4.6/V5.0/V5.1, SP0005 to SP1014, or V6.0/V6.5 SP0000 to SP1009; Aplio a550 CUS-AA550/ 04987670103353, Aplio a450 CUS-AA450/ 04987670103346, With System Version: V3.0, SP0005 to SP1014, or V4.0/V4.5, SP0000 to SP1009

Devices named in this recall

5 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page