Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector
Medical device recall Z-0622-2017. Published in FDA’s Enforcement Report on Nov 30, 2016.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Nov 30, 2016. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 291 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation allows rapid data acquisition and shortens scan times, while the fast reconstruction unit further improves throughput, reducing the time required for diagnosis.
291 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
5LA1392001 5LA1392002 5LA1392004 5LA13X2005 5LA13X2006 5LA13X2007 5LA13X2008 5LA13X2010 5LA13Y2011 5LA13Y2012 5LA13Y2013 5LA13Y2014 5OA13Y2015 5OA13Y2016 5LA13Y2017 5DA13Z2018 5LA13Z2019 5LA13Z2020 5LA13Z2021 5LA13Z2022 5LA13Z2023…
Every code shown here, 1,991 characters
5LA1392001 5LA1392002 5LA1392004 5LA13X2005 5LA13X2006 5LA13X2007 5LA13X2008 5LA13X2010 5LA13Y2011 5LA13Y2012 5LA13Y2013 5LA13Y2014 5OA13Y2015 5OA13Y2016 5LA13Y2017 5DA13Z2018 5LA13Z2019 5LA13Z2020 5LA13Z2021 5LA13Z2022 5LA13Z2023 5LA13Z2024 5LA13Z2025 5DA13Z2026 5LA13Z2027 5LA1412028 5LA1412029 5LA1412030 5LA1412031 5DA1422032 5LA1422033 5DA1422034 5LA1422035 5LA1422036 5LA1422037 5DA1422038 5LA1422039 5GA1422040 5OA1422041 5DA1422042 5DA1422043 5OA1422044 5DA1432045 5LA1432046 5DA1432047 5GA1432048 5LA1442050 5DA1442051 5LA1442052 5OA1442053 5DA1442054 5LA1452055 5DA1452056 5DA1452057 5DA1452058 5DA1452059 5LA1452060 5OA1452061 5LA1452062 5DB1462063 5LB1462064 5LB1462065 5DB1462066 5LB1462067 5GB1462068 5DB1462069 5DB1462070 5DB1462071 5DB1462072 5DB1472073 5DB1472074 5LB1472075 5LB1472076 5LB1472077 5OB1472078 5LB1472080 5LB1482081 5DB1482082 5DB1482083 5LB1482084 5LB1482085 5DB1482086 5DB1482087 5DB1482088 5DB1492089 5DB1492090 5LB14X2091 5DB14X2092 5GB14X2093 5LB14X2094 5LB14X2096 5GB14X2097 5LB14X2098 5LB14X2099 5LB14X2100 5DB14Y2101 5DB14Y2102 5LB14Y2103 5GB14Y2104 5DB14Y2105 5DB14Y2106 5DB14Y2107 5LB14Y2108 5LB14Y2109 5DB14Z2110 5DB14Z2111 5DB14Z2112 5LB14Z2113 5GB14Z2114 5LB14Z2115 5LB14Z2116 5DB14Z2117 5DB14Z2118 5DB14Z2119 5LB14Z2120 5DB14Z2121 5DB14Z2122 5DB14Z2123 5GB14Z2124 5DB14Z2125 5DB1512126 5DB1512127 5LB1512128 5LB1512129 5DB1512130 5DB1512131 5DB1512132 5DB1512133 5GB1512134 5LB1512135 5OB1512136 5DB1512137 5DB1522138 5DB1522139 5DB1522140 5DB1522141 5GB1522142 5LB1522143 5DB1522144 5DB1522145 5DB1522146 5DB1522147 5GB1522148 5DB1522149 5DB1522150 5DB1522151 5DB1522152 5LB1542153 5GB1542154 5LB1542155 5LB1542156 5GB1542157 5LB1542158 5OB1542159 5GB1542160 5LB1542161 5LB1542162 5LB1552163 5LB1552164 5DB1552165 5LB1552166 5LB1552167 5DB1552168 5LB1552169 5DB1562170 5DB1562171 5LB1562172 5OB1562173 5DB1562174 5LB1562175 5LB1562176 5LB1562177 FLB1572001 FLB1572002 FLB1572003 FLB1572004 FLB1572005 FLB1572006 FLB1572007 FLB1572008 FLB1572009…
FDA’s list runs to 3,288 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide Distribution
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Oct 25, 2016.
- FDA classified it on Nov 18, 2016.
- FDA’s Enforcement Report published it on Nov 30, 2016.
- FDA terminated it on Aug 19, 2017.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Toshiba American Medical Systems Inc, of Tustin, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 3,288 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.