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
5LA13920015LA13920025LA13920045LA13X20055LA13X20065LA13X20075LA13X20085LA13X20105LA13Y20115LA13Y20125LA13Y20135LA13Y20145OA13Y20155OA13Y20165LA13Y20175DA13Z20185LA13Z20195LA13Z20205LA13Z20215LA13Z20225LA13Z20235LA13Z20245LA13Z20255DA13Z20265LA13Z20275LA14120285LA14120295LA14120305LA14120315DA14220325LA14220335DA14220345LA14220355LA14220365LA14220375DA14220385LA14220395GA14220405OA14220415DA14220425DA14220435OA14220445DA14320455LA14320465DA14320475GA14320485LA14420505DA14420515LA14420525OA14420535DA14420545LA14520555DA14520565DA14520575DA14520585DA14520595LA14520605OA14520615LA14520625DB1462063
- 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.
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