FDA (Devices) recall action 84954
The FDA (Devices) publishes a recall like this one as 8 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 8 pages.
Scanning may be interrupted due to an error during execution of the eXam Plan and the system is unable to be shut down normally, resulting in the need to forcibly turn the system power off and reboot. Loss of the acquired raw data would occur.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Canon Medical System is recalling one Aquilion Precision CT scanner because a software error may interrupt scanning and cause loss of raw data.
Canon Medical System is recalling 35 Aquilion One CT scanners because a software error may interrupt scanning and prevent normal shutdown, causing loss of raw data.
Canon Medical System is recalling six Aquilion Lightning CT scanners because a software error can interrupt scanning and prevent normal shutdown, causing loss of raw data.
Canon Medical System is recalling two Aquilion One CT scanners because scanning errors may interrupt exams and force system reboots, resulting in the loss of acquired raw data.
Canon Medical System is recalling 10 Aquilion Prime SP CT scanners because a software error may interrupt scanning and cause loss of raw data.
Canon Medical System is recalling 10 Aquilion Prime CT scanners because a software error may interrupt scanning and prevent normal shutdown, resulting in data loss.
Canon Medical System is recalling one Aquilion One Vision CT scanner because a software error can interrupt scans and cause loss of raw data.
Canon Medical System is recalling two Aquilion Premium CT scanners because a software error can interrupt scans and cause loss of raw data.