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Recall Observatory FDA recall evidence

Device product

Canon Aquilion One, Model TSX-301A

Z-1720-2020

March 25, 2019

Class II

Product summary

Firm
Canon Medical System, USA, INC.
Event
Event 84954
Status
Ongoing
Classification
Class II
Quantity
2 devices
Official record key
device-enforcement:Z-1720-2020

Official wording

Reason: 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.

Code information: Canon Aquilion ONE Whole-Body X-Ray CT Scanner, TSX-301A - Serial number 7CA1892001and 7CA1892002.

Distribution pattern: Distribution was made to AK, AR, CA, FL, IA, ID, IL, KS, MA, MD, MI, MN, MO, MT, NC, ND, NH, NY, OH, OK, OR, PA, TN, TX, VT, WA, WI, and WV. There was government and military distribution but no foreign distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.