FDA Recall Open, Classified

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

Recall: Z-0198-2023 · Initiated September 29, 2022

Recall

Recall Number: Z-0198-2023
Event Number: 90980
Firm: Canon Medical System, USA, INC.
FEI Number: 2020563
Product Code: IYN
Status: Open, Classified
Root Cause: Software Design Change
Initiated: September 29, 2022
Posted: November 8, 2022
Address: 2441 Michelle Dr, Tustin, CA, 92780-7047

Description

Reason

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.

Action

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].

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

Quantity