Recall Z-2188-2016— Toshiba American Medical Systems Inc

Name: FDA recall Z-2188-2016
Creator: U.S. Food and Drug Administration
Published: 2016-02-24

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2016-02-24, terminated 2017-04-25. It names one FDA 510(k) clearance: K150967. Product: Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System. 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..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2016-02-24
Terminated: 2017-04-25
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K150967 — XIDF-AWS801, Angio Workstation, V6.10Toshibamedical Systems Corporation·cleared 2015-06-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Toshiba America Medical Systems Angio WorkStation: XIDF-AWS801v6.00, v6.01, and V6.10 System: INFX-8000V Bi-Plane System

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.