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.
Reported: October 6, 2021 Initiated: August 2, 2021 #Z-2594-2021
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.
Details
- Recalling Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Units Affected
- 1 system
- Distribution
- U.S. Nationwide distribution in the states of CA, IL, IN, TX, and WI.
- Location
- Shanghai, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shanghai United Imaging Healthcare Co., Ltd.. Units affected: 1 system.
Why was this product recalled? ▼
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 6, 2021. Severity: Moderate. Recall number: Z-2594-2021.
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