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

FDA device recall Z-0198-2023 · posted 2022-11-08 · Open, Classified

Recall details

Recalling firm

Canon Medical System, USA, INC.

Reason for recall

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 taken

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 intouchdispatch@us.medical.canon.

Root cause

Software Design Change

Status

Open, Classified

Product code

IYN

Quantity affected

65

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

Date initiated

2022-09-29

Date posted

2022-11-08

Location

Tustin, CA

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