Reported Nov 16, 2022 · Ongoing
Canon Aplio ultrasound system, Model: Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, Aplio a550…
Canon Medical System, USA, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Canon Medical System, USA, INC. · 2441 Michelle Dr · Tustin, CA · 92780-7047
Is this the product you have?
- Canon Aplio ultrasound system
- Model
Aplio i900 TUS-AI900Aplio i800 TUS-AI800Aplio i700 TUS-AI700Aplio a550 CUS-AA550Aplio a450 CUS-AA450
- Lot codes and dates
- Model/UDI-DI
- with software
Aplio i900 TUS-AI900/ 04987670102523Aplio i800 TUS-AI800/ 04987670102516Aplio i700 TUS-AI700/ 04987670102509
- With System Version
V4.6/V5.0/V5.1SP0005 to SP1014or V6.0/V6.5 SP0000 to SP1009Aplio a550 CUS-AA550/ 04987670103353Aplio a450 CUS-AA450/ 04987670103346
- With System Version
V3.0SP0005 to SP1014or V4.0/V4.5SP0000 to SP1009
- Amount recalled
- 65
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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