Canon recalls Aplio i900, i800, i700, and a550 ultrasound systems with software versions V4.6-V6.5 that may display incorrect images during patient exams, causing treatment delays.
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.
Canon is recalling specific ultrasound systems that may show incorrect images during patient exams, potentially delaying treatment. This happens if the system doesn't properly save images after a scan due to a software issue.
The ultrasound system may not save images properly after a scan. If the user doesn't manually stop the protocol, the system shows a message asking if the saved image should be used with StressEcho Review. Choosing 'yes' assigns the image to the previous patient, causing treatment delays.
Healthcare providers using Canon Aplio ultrasound systems with specific software versions are affected. Patients receiving scans on these systems may experience delayed treatment if the system displays incorrect images.
Check for model numbers: Aplio i900, i800, i700, or a550. Look for software versions V4.6/V5.0/V5.1 (SP0005 to SP1014) or V6.0/V6.5 (SP0000 to SP1009) for i-series models, or V3.0 (SP0005 to SP1014) or V4.0/V4.5 (SP0000 to SP1009) for a-series models.
Review the system's software version to determine if it falls within the recalled versions listed in the notice.
The affected models are Canon Aplio i900 TUS-AI900, Aplio i800 TUS-AI800, Aplio i700 TUS-AI700, and Aplio a550 CUS-AA550 with specific software versions.
The ultrasound system may not save images properly after a scan if the user doesn't manually terminate the protocol, which can cause treatment delays.
Check the model number and software version against the list provided in the recall notice.
We’ve drafted a message you can send Canon to request your refund or repair — edit it as you like.
Subject: Recall Z-0198-2023 — Canon Canon Hello, I own a Canon that is covered by recall Z-0198-2023 from Canon. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
