Recall Z-2109-2017— Toshiba American Medical Systems Inc

Name: FDA recall Z-2109-2017
Creator: U.S. Food and Drug Administration
Published: 2017-02-01

Class II · Terminated

Class II FDA medical device recall by Toshiba American Medical Systems Inc, initiated 2017-02-01, terminated 2018-06-06. It names one FDA 510(k) clearance: K152785. Product: Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F. Reason: 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..

Recalling firm: Toshiba American Medical Systems Inc
Classification: Class II
Status: Terminated
Initiated: 2017-02-01
Terminated: 2018-06-06
Firm location: Tustin, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K152785 — XIDF-AWS801, Angio Workstation, V6.20Toshibamedical Systems Corporation·cleared 2015-11-25

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

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

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.

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