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.
FDA Recall Z-0622-2017 · Posted 2016-11-18
Recalling FirmToshiba American Medical Systems Inc
Recall StatusTerminated
Product CodeJAK
Date Initiated2016-10-25
Date Terminated2017-08-19
Product Quantity291 units
Reason for Recall
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.
Firm Action
Toshiba American Medical Systems, Inc. sent an Urgent Medical Device Correction letter dated October 25, 2016, to all affected customers who received the Aquilion CT system to inform them that Toshiba America Medical System has received reports that the cooling oil in the x-ray tube heat exchanger may leak during system operation. The letter informs the customers of the description found and corrective action. Customers were instructed to complete the attached customer reply form and fax it to (877) 349-3054 or send it to [email protected]. Customers with questions are instructed to call (800) 421-1968 or contact their local Toshiba Representative at (800) 521-1968.
For questions regarding this recall call 714-730-5000.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.