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Open, Classified

Canon Aquilion One, Model TSX-301A

FDA Recall Z-1720-2020 · Posted 2020-04-10

Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2019-03-25
Product Quantity2 devices

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.

Firm Action

Recall letters dated 3/25/2019 were issued on 3/25/2019 via USPS return receipt mail.

Root Cause

Software design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K093891AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2Toshibamedical Systems Corporation · 2010-11-18

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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