Z-2799-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 19, 2020
- Initiation Date
- July 16, 2020
- Termination Date
- July 7, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit distributed to Texas
Product Description
uEXPLORER PET/CT Diagnostic Imaging System - Product Usage: This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Reason for Recall
1) 1) Potential intermittent issue may cause image data problems, may lead to artifacts; 2) Potential intermittent scout scanning interruption due to angle signal drift caused by external interference; 3) Metal edge overlap of mylar strip in gantry may create sharp edge. May lead to repeat scanning and abrasions.
Distribution Pattern
US Nationwide distribution including in the state of Texas.
Code Information
Serial No. F00002; GTIN 06971576832040