Toshiba Aquilion Prime CT System Recalled for Cooling Oil Leak Risk
Toshiba American Medical Systems is recalling Aquilion Prime CT systems because cooling oil in the x-ray tube heat exchanger may leak during operation.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a potential leak of cooling oil in a medical device, which poses a risk of harm (equipment failure or exposure) but the source text does not report any injuries or illnesses, fitting the 'High' criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Toshiba American Medical Systems (TAMS) is recalling the Aquilion Prime CT system (model TSX-303A). This device is a multislice helical CT system with a 40-row detector used for medical imaging.
The recall was initiated because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system operation. The source text does not specify the number of affected units, the distribution scope, or any reported injuries or illnesses.
Healthcare facilities should contact Toshiba American Medical Systems for instructions on how to address the potential leak. The source text does not provide specific consumer action steps or contact details.
The recalled product
- 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.
- Manufacturer
- Toshiba American Medical Systems Inc
- Category
- Medical Device — CT Scanner
- Affected units
- 291
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Toshiba American Medical Systems Inc
See all →- ModerateToshiba Diagnostic Ultrasound Systems Recalled for Power Supply Defect
FDA (Devices) · 2018-07-04
- ModerateToshiba INFX-8000H Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
FDA (Devices) · 2018-03-14
- HighToshiba INFX-8000C Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
FDA (Devices) · 2018-03-14
- HighToshiba Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Bolt Loosening
FDA (Devices) · 2018-03-14
- HighToshiba INFX-8000F Fluoroscopic X-Ray Systems Recalled for Ceiling Drive Defect
FDA (Devices) · 2018-03-14
Same hazard · chemical leak
See all →- HighBrenner Tank Recalls 2026 TKQXFR Trailers Due to Valve Defect
NHTSA · 2025-10-10
- HighBauer Battery-Powered Backpack Sprayers Recalled for Fire Hazard
CPSC · 2024-10-31
- HighMedical Device Kits Recalled for Leaking Isopropyl Alcohol
FDA (Devices) · 2022-08-03
- HighMedline medical device kits recalled for leaking isopropyl alcohol bottles
FDA (Devices) · 2022-08-03
- HighMedline Custom Surgical Kits Recalled for Leaking Isopropyl Alcohol Bottles
FDA (Devices) · 2022-08-03