FDA Device recall Z-2109-2017
Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F
- FDA Device
- Class II
- terminated
- Published 2017-06-07
On 2017-06-07 the FDA classified a Class II recall of Angio WorkStation (XIDF-AWS801) used in conjunction with your Infinix System (INFX-8000V;INFX-8000C;INFX-8000F by Toshiba American Medical Systems, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2109-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-02-01 |
| Published | 2017-06-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Toshiba American Medical Systems |
| Distribution | AL, AR, CA, CT, DE, FL, GA, ID, IL, IN, LA, MA, MD, MN, MO, MS, NC, NH, NJ, NV, NY, OH, OK, PA, TN, TX, VA, WA |
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.
Identifiers
| code_info | S/N : 8181622393 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2109-2017%22
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