Toshiba Recalls Cardiac Function Analysis Software Due to Incorrect Results
Toshiba American Medical Systems is recalling two units of cardiac function analysis software because it may display incorrect analysis results for heart function.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a 'Severe' severity score under the rubric, as it involves a significant risk of temporary or medically reversible adverse health consequences.
Plain-English summary
Toshiba American Medical Systems Inc is recalling two units of Cardiac Function Analysis Software (CFA) in the United States. The software is applicable to the Aquilion ONE TSX-301A/2D X-ray CT systems. The specific units affected have serial numbers 1BA07X2002 and 1BA07X2001.
The recall is due to a potential problem where the software may display incorrect analysis results in the Function Parameters for the Entire Heart and in a Left-Ventricular Volume Curve. These results are generated based on some of the parameters used by the CFA.
The affected software was distributed nationwide to California, Massachusetts, and Maryland. The U.S. Food and Drug Administration has classified this as a Class II recall. Users of the affected CT systems should contact Toshiba American Medical Systems for further instructions regarding the software issue.
The recalled product
- Product
- Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE TSX-301A/2D X-ray CT system with a 320-row 0.5 mm detector is provided with a 7.5-MHU large-capacity X-ray tube unit, and…
- Manufacturer
- Toshiba American Medical Systems Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 2
Distribution
Part of a larger recall action
This product is one of 2 recalled by Toshiba American Medical Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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