FDAFDA · Food and drugs·Recall number Z-1723-2020
Canon Aquilion Prime, Model TSX-303A
Published April 22, 2020 · Recall initiated: March 25, 2019
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Canon Medical System, USA, INC.
- Distributor
- 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.
- Lot
- Canon Aquilion PRIME, TSX-303A - Serial numbers 1CB1892050, FLC1882279, FLC1892282, FLC1882278, FLC18Y2301, FLC1892288, FOC1892284, FOC1872277, FOC18X2289, and FOC18Y2296.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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