FDA Device recall Z-0622-2017
Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector
- FDA Device
- Class II
- terminated
- Published 2016-11-30
On 2016-11-30 the FDA classified a Class II recall of Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector by Toshiba American Medical Systems, citing 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 syst….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0622-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-10-25 |
| Published | 2016-11-30 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | 5LA1392001 5LA1392002 5LA1392004 5LA13X2005 5LA13X2006 5LA13X2007 5LA13X2008 5LA13X2010 5LA13Y2011 5LA13Y2012…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 5DB1 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0622-2017%22
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