Reported Nov 18, 2020 · Ongoing
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product…
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 Tomography and Computed Tomography System, Model uMI 550, Rx, CE
- GTIN06971576832026 -
- 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
- Serial Numbers
200017200023200024200036200045200047230002230003230004
- Serial Numbers
- Amount recalled
- 9
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
- TX
Why it was recalled
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
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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