Cardiac Function Analysis Software Product Data No. recall: Software Issue
Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE…
Why was Cardiac Function Analysis Software Product Data No. recalled?
Potential problem with the cardiac function analysis software (CFA). Incorrect analysis results may be displayed in the Function Parameters for the Entire Heart displayed as analysis results of the CFA and in a Left-Ventricular Volume Curve generated based on some of those parameters.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item CFA Software Serial Number: Description TSX-301C/2D 2BA1362093 Aquilion One Vision
- Product
- Cardiac Function Analysis Software Product Data No. MPDCT0301EAD CSCF-003A The software is applicable to the following CT systems: Aquilion ONE…
- Recalling firm
- Toshiba American Medical Systems Inc
- Quantity
- 1 unit within the U.S. only
- Distribution
- US Nationwide Distribution to CA, MA, MD
- Recall date
- December 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)