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
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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
Product Codes/Lot 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
Distribution:
Nationwide distribution
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0198-2023
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