Reported Aug 5, 2020 · Ongoing
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to…
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?
- Computed Tomography X-ray System; Model uCT 530; Rx
- UDI(01)
- GTIN06971576831012 -
- Product Usageintended to produce cross-sectional images of the body using computer reconstruction of x-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck, cardiac, and vascular)
- Lot codes and dates
SN 300162300163300174300176
- Amount recalled
- 4
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
This product could cause temporary or reversible health problems — stop using it.
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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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