Reported Oct 6, 2021 · Ongoing
uEXPLORER PET/CT System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the…
Shanghai United Imaging Healthcare Co., Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Shanghai United Imaging Healthcare Co., Ltd. · No. 2258 Chengbei Rd, Jiading Ind. · Shanghai, N/A · N/A
Is this the product you have?
- uEXPLORER PET/CT System - Product Usageintended 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
- Lot codes and dates
- Model88000025
- GTIN/UDI Code06971576832040 / 01 06971576832040 240 88000025 21
- F00002 Serial NumbersF00002
- Amount recalled
- 1 system
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
The EXAM acquisition workflow could occasionally freeze after canceling the PET scan.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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