Toshiba American Medical Systems Inc: Medical Device Recall in 2017 - (Recall #: Z-2109-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F

Product Classification:

Class II

Date Initiated: February 1, 2017

Date Posted: June 7, 2017

Recall Number: Z-2109-2017

Event ID: 77195

Reason for Recall:

It was found that during a procedure the Peak Skin Dose (PSD) value displayed by the Dose Tracking System (DTS) was larger than the DTS expected value. This issue occurs when the power for the Angio Workstation is turned on after the power for the Infinix system is turned on.

Status: Terminated

Product Quantity: US - 70 systems

Code Information:

S/N : 8181622393

Distribution Pattern:

US Distribution to the states of :LA, IL, NY, FL, MA, TN, MO, GA, CA, DE, MO, AL, ID, MN, TX, CT, PA, MS, OH, NC, NV, W VA, WA, AR, NJ, MD, OK, IN and NH.

Voluntary or Mandated:

FDA Mandated