Toshiba Aquilion One CT System Recalled for Abnormal Analysis Results
Toshiba American Medical Systems is recalling three Aquilion One CT systems because the SureStart function may fail, leading to abnormal cerebral blood flow analysis results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device where a functional defect may lead to abnormal diagnostic results (cerebral blood flow analysis). Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported, and the agency classification is Class II.
Plain-English summary
Toshiba American Medical Systems Inc. is recalling three units of the TSX-301A/2 Aquilion One CT System. These are whole-body CT scanners used to capture cross-sectional volume data sets of anatomy and provide data for dynamic and perfusion studies. The affected units were distributed nationwide in the United States, specifically in Massachusetts, Maryland, and Nevada.
The recall is due to a defect where the SureStart function may not operate in the usual manner. This malfunction may result in abnormal analysis results when the device is used for cerebral blood flow analysis. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities should contact Toshiba American Medical Systems for instructions on how to address the issue with the SureStart function. The recall number for this action is Z-2468-2012.
The recalled product
- Product
- TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole body CT scanner. This device captures cross sectional volume data sets. The device consists of a gantry, patient couch (table) and peripheral cabinets used for data processing and display. This device is intended…
- Manufacturer
- Toshiba American Medical Systems Inc
- Category
- Medical Device — CT Scanner
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Item number TSX-301 A/2D Serial Numbers: 2DA0792004
- 2DA07X2005
- 2DA07Y2010
- 2DA0792002
- 2DA07X2008
- 2DA0842023.
Distribution
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