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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84954

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 25, 2019
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Canon Medical System, USA, INC.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Canon Aquilion Lightning, Model TSX-036A

Z-1719-2020
Recall number
Z-1719-2020
Initiated
March 25, 2019
Classification
Class II
Status
Ongoing
Quantity
6 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.

device · product 2 of 8

Canon Aquilion One, Model TSX-301A

Z-1720-2020
Recall number
Z-1720-2020
Initiated
March 25, 2019
Classification
Class II
Status
Ongoing
Quantity
2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.

device · product 3 of 8

Canon Aquilion Premium, Model TSX-301B

Z-1721-2020
Recall number
Z-1721-2020
Initiated
March 25, 2019
Classification
Class II
Status
Ongoing
Quantity
2 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

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.

device · product 4 of 8

Canon Aquilion One Vision, Model TSX-301C

Z-1722-2020
Recall number
Z-1722-2020
Initiated
March 25, 2019
Classification
Class II
Status
Ongoing
Quantity
1 device

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.

device · product 5 of 8

Canon Aquilion Prime, Model TSX-303A

Z-1723-2020
Recall number
Z-1723-2020
Initiated
March 25, 2019
Classification
Class II
Status
Ongoing
Quantity
10 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.

device · product 6 of 8

Canon Aquilion Prime SP, Model TSX-303B

Z-1724-2020
Recall number
Z-1724-2020
Initiated
March 25, 2019
Classification
Class II
Status
Ongoing
Quantity
10 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.

device · product 7 of 8

Canon Aquilion Precision, Model TSX-304A

Z-1725-2020
Recall number
Z-1725-2020
Initiated
March 25, 2019
Classification
Class II
Status
Ongoing
Quantity
1 device

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

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.

device · product 8 of 8

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

Z-1726-2020
Recall number
Z-1726-2020
Initiated
March 25, 2019
Classification
Class II
Status
Ongoing
Quantity
35 devices

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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.

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.