Canon Medical System, USA, INC.: Medical Device Recall in 2020 - (Recall #: Z-1721-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Canon Aquilion Premium, Model TSX-301B

Product Classification:

Class II

Date Initiated: March 25, 2019

Date Posted: April 22, 2020

Recall Number: Z-1721-2020

Event ID: 84954

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 2 devices

Code Information:

Canon Aquilion Whole-Body X-Ray CT Scanner, 160-detector row CT, Model TSX-301B - Serial numbers 7CA18Y2002 and 7CA1892001.

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.

Voluntary or Mandated:

Voluntary: Firm initiated