Recall Z-2188-2016 ยท OWB Interventional Fluoroscopic X-Ray System
Toshiba American Medical Systems Inc
Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System
| Date | Jul 18, 2016 (initiated Feb 24, 2016) |
| Status | Terminated |
| Reason | During a procedure the Peak Skin Dose (PSD) value was displayed on the DTS larger than the DTS expected value. It was found that the software incorrectly calculated the PSD value when the x-ray condition of the frontal plane and the lateral plane are the same. It incorrectly used in the calculation a dose value from a previous exposure. |
| Root cause | Radiation Control for Health and Safety Act |
| Action | Toshiba Medical Systems (TAMS) planned action to bring product into Compliance: 1.TAMS will install the software and perform testing to ensure the software update was effective. 2. The customer notification letter which includes a statement that TAMS will, without charge, remedy the defect or bring the product into compliance. . If you have any questions regarding this, please feel free to contact your local Toshiba representative at (800) 521-1968. |
| Quantity | 23 |
| Distribution | US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150967 | XIDF-AWS801, Angio Workstation, V6.10 Toshibamedical Systems Corporation, Jun 18, 2015 |