Is Canon Aquilion Lightning, Model TSX-036A recalled?

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: Voluntary: Firm initiated Initial Firm Notification: Letter Distribution: 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.

Medium RiskFDA Device

Canon Medical System, USA, INC.: 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.

Agency Publication Date: April 10, 2020

Affected Products

Product: Canon Aquilion Lightning, Model TSX-036A

Canon Aquilion Lightning, TSX-036A - Serial numbers 4LC1892122, 4LC1892125, 4LC1892129, 4LC1882114, 4OC1912163, and 4OC18Y2149.

Product: Canon Aquilion One, Model TSX-301A

Canon Aquilion ONE Whole-Body X-Ray CT Scanner, TSX-301A - Serial number 7CA1892001and 7CA1892002.

Product: Canon Aquilion Premium, Model TSX-301B

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

Product: Canon Aquilion One Vision, Model TSX-301C

Canon Aquilion ONE, Whole-Body X-Ray CT Scanner, Model TSX-301C - Serial number 3DC18Y2118.

Product: Canon Aquilion Prime, Model TSX-303A

Canon Aquilion PRIME, TSX-303A - Serial numbers 1CB1892050, FLC1882279, FLC1892282, FLC1882278, FLC18Y2301, FLC1892288, FOC1892284, FOC1872277, FOC18X2289, and FOC18Y2296.

Product: Canon Aquilion Prime SP, Model TSX-303B

Canon Aquilion Prime SP, Multislice Helical CT Scanner, Model TSX-303B - Serial numbers 1LB1882092, 1LB1882088, 1LB18X2111, 1LB1882086, 1LB18X2129, 1LB18X2109, 1LB1882087, 1LB1882090, 1LB1892093, and 1OB1892102.

Product: Canon Aquilion Precision, Model TSX-304A

Canon Aquilion Precision, Whole-Body X-Ray CT Scanner, Model TSX-304A, Serial number 2DB1892018.

Product: Canon Aquilion One, Model TSX-305A/3 V8.3 with FIRST 2.1

Canon Aquilion ONE GENESIS Edition, Whole-Body X-Ray CT Scanner, Model TSX-305A - Serial number 3LA1652001, 3LA17Y2020, 3LB1872025, 3LA1762010, 3LA1772012, 3LA1762009, 3LB1882026, 3LA1752007, 3LA1762008, 3LA1772013, 3LA1732006, 3LA1772015, 3LA1772014, 3LA16Y2003, 3LA1792017, 3LA1782016, 3LA1712005, 3LB1832021, 3LA16Z2004, 3LA17Y2019, 3LB1842022, 3LA1772011, 3LB1852024, 3LA17X2018, 3OB1852023, 6LB18Y2013, 6LB1892008, 6LB1862002, 6LB1882007, 6LB1852001, 6LB1892009, 6LB18Y2011, 6LB1872005, 6LB1872006, and 6OB1862003.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 84954

Status: Active

Manufacturer: Canon Medical System, USA, INC.

Manufactured In: United States

Units Affected: 8 products (6 devices; 2 devices; 2 devices; 1 device; 10 devices; 10 devices; 1 device; 35 devices)

Agency Last Updated: April 16, 2020

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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