Reported Nov 30, 2016 · Terminated

Aquilion Prime TSX-303A Aquilion PRIME is a multislice helical CT system with an 40-row detector. High-speed rotation…

Toshiba American Medical Systems Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Toshiba American Medical Systems Inc · PO Box 2068 · Tustin, CA · 92780-7047

Is this the product you have?

  • 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.
Lot codes and dates
  • 299 of 299 codes

    • 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
Amount recalled
291 units

Where it was sold

  • Nationwide

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 19, 2017 · Data as of Sep 19, 4:46 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.