Toshiba Cardiac Function Analysis Software Recalled for Incorrect Results
Toshiba American Medical Systems is recalling one unit of cardiac function analysis software in the US because it may display incorrect analysis results.
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 medical device where incorrect analysis results could lead to misdiagnosis or improper treatment, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Toshiba American Medical Systems Inc is recalling one unit of Cardiac Function Analysis Software (CFA) in the United States. The software, identified by Product Data No. MPDCT0301EAD and CSCF-003A, is applicable to the Aquilion ONE TSX-301C X-ray CT system. The specific unit affected has the serial number 2BA1362093.
The recall was initiated because the software may display incorrect analysis results in the Function Parameters for the Entire Heart and in a Left-Ventricular Volume Curve. These parameters are generated based on the analysis results of the CFA. The software is used to analyze cardiac function using data obtained by performing cardiac MPR processing for ECG-gated scan data.
The affected unit was distributed nationwide to California, Massachusetts, and Maryland. The source text does not specify the actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the use of this software.
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-301C 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 permits sca
- Manufacturer
- Toshiba American Medical Systems Inc
- Category
- Medical Device — Software
- Hazard
- Affected units
- 1
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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