Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1
FDA Recall Z-1726-2020 · Posted 2020-04-10
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Recalling FirmCanon Medical System, USA, INC.
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2019-03-25
Product Quantity35 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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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