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U.S. Department of Health and Human Services

Class 2 Device Recall Canon Aplio ultrasound system

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  Class 2 Device Recall Canon Aplio ultrasound system see related information
Date Initiated by Firm September 29, 2022
Date Posted November 08, 2022
Recall Status1 Open3, Classified
Recall Number Z-0198-2023
Recall Event ID 90980
510(K)Number K212960  K212333  
Product Classification System, imaging, pulsed doppler, ultrasonic - Product Code IYN
Product 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 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
Recalling Firm/
Manufacturer		 Canon Medical System, USA, INC.
2441 Michelle Dr
Tustin CA 92780-7047
For Additional Information Contact
714-730-5000
Manufacturer 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.
FDA Determined
Cause 2		 Software Design Change
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 intouchdispatch@us.medical.canon.
Quantity in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = IYN and Original Applicant = Canon Medical Systems Corporation
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