Z-2109-2017 Class II Terminated
FDA device recall Z-2109-2017 was initiated by Toshiba American Medical Systems Inc on February 1, 2017 and is designated Class II. 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 W… The recall status is terminated (terminated June 6, 2018). Affected quantity: US - 70 systems.
Recall Details
- Product Type
- Devices
- Report Date
- June 7, 2017
- Initiation Date
- February 1, 2017
- Termination Date
- June 6, 2018
- Voluntary/Mandated
- FDA Mandated
- Product Quantity
- US - 70 systems
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.
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.
Code Information
S/N : 8181622393