Reported Nov 18, 2020 · Ongoing
Computed Tomography X-Ray System, Model uCT 530, Rx, CE, GTIN: 06971576831012 - Product Usage: ntended to produce…
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?
- Computed Tomography X-Ray System, Model uCT 530, Rx, CE
- GTIN06971576831012 -
- Product Usagentended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, vascular)
- Lot codes and dates
- Serial Numbers
3000162300163300174300176
- Serial Numbers
- Amount recalled
- 4
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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