Shanghai United Imaging Healthcare Co., Ltd. Recall 88521
Description: uEXPLORER PET/CT System - Product Usage: 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.
Shanghai United Imaging Healthcare Co., Ltd. Recall 88521 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2594-2021 |
| Event ID | 88521 |
| Event Description | uEXPLORER PET/CT System - Product Usage: 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. |
| Product Type | Devices |
| Distribution | U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI. |
| Quantity | 1 system |
| Recall Reason | The EXAM acquisition workflow could occasionally freeze after canceling the PET scan. |
| Device Classification | 20211006 |
| Device Code Info | Model: 88000025 GTIN/UDI Code: 06971576832040 / 01 06971576832040 240 88000025 21 F00002 Serial Numbers: F00002 |
| Center Classification Date | 20210929 |
| Recall Initiation Date | 20210802 |
| Recalling Firm | Shanghai United Imaging Healthcare Co., Ltd. |
| Initial Notification | Letter |
| Similar To |