Recall Z-0472-2015 ยท JAK System, X-Ray, Tomography, Computed
Toshiba American Medical Systems Inc
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 permits scanning over large areas at the high-speed of 0.35 s per rotation. The system features are; 160-mm-wide area detector, st
| Date | Nov 26, 2014 (initiated Nov 5, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Software design |
| Action | Toshiba sent an Urgent Medical Device Correction letter dated November 5, 2014, to all affected customers. Customers were asked to refrain from using the function parameters for the entire heart and the left-ventricular volume curve until corrective actions have been taken. Customers were instructed to share this information with all users and reviewing radiologist as well as clinical engineering or Biomedical group at facility. Please complete and return the attached form and fax it to the toll free number at the top of the form 877-349-3054. This form can also be sent via email to raffairs |
| Quantity | 2 units within the U.S. only |
| Distribution | US Nationwide Distribution to CA, MA, MD |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113466 | AQUILION ONE Toshiba Medical Systems Coporation, Japan, Apr 10, 2012 |