Reported Apr 22, 2020 · Terminated
Positron Emission Tomograpy and Computed Tomography System, Model: uMI 550, with software version R001.3.0.0.750505, Rx…
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
Is this the product you have?
- Positron Emission Tomograpy and Computed Tomography System
- Model
uMI 550with software version R001.3.0.0.750505Rx OnlyCE 0197
- UDI(01)06971576832026 -
- Product UsageThis 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
- Lot codes and dates
- Serial Numbers200017 and 200023
- Amount recalled
- 2 units
Where it was sold
- Nationwide
- TX
Why it was recalled
Potential sporadic software bugs in R001.3.0.0.750505 software version may cause an issue with the PET acquisition raw data causing reconstruction problems during PET/CT scanning and could possibly cause rescans of patients with additional dose.
This product could cause temporary or reversible health problems — stop using it.
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