Toshiba American Medical Systems Inc: Medical Device Recall in 2016 - (Recall #: Z-2188-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 24, 2016

Date Posted: July 27, 2016

Recall Number: Z-2188-2016

Event ID: 74473

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.

Status: Terminated

Product Quantity: 23

Code Information:

Model Number - XIDF-AWS801

Distribution Pattern:

US Distribution to the states of : NC, NY, TX, GA, CA, AZ, IL, FL,MA, MO and DE.

Voluntary or Mandated:

FDA Mandated