Recall Z-2594-2021— Shanghai United Imaging Healthcare Co., Ltd.
Class II · Ongoing
Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2021-08-02. It names 2 FDA 510(k) clearances: K193241, K182237. Product: 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.. Reason: The EXAM acquisition workflow could occasionally freeze after canceling the PET scan..
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-08-02
- Firm location
- Shanghai, N/A, China
510(k) clearances named in this recall
2 on FDA's recordK-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
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.
Reason for recall
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Data sourced from openFDA. This site is unofficial and independent of the FDA.