medical Class II Updated 2020-04-22

Canon Medical System, USA, INC. recalls Canon Aquilion Premium, Model TSX-301B

Recalled Product

Canon Aquilion Premium, Model TSX-301B


Hazard / Issue

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.

Issued by

FDA

Affected States: 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, WV
Lot/Code Info: Canon Aquilion Whole-Body X-Ray CT Scanner, 160-detector row CT, Model TSX-301B - Serial numbers 7CA18Y2002 and 7CA1892001.
View official government recall

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