Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended 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).
Reported: August 5, 2020 Initiated: June 20, 2020 #Z-2704-2020
Product Description
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended 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).
Reason for Recall
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Details
- Recalling Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Units Affected
- 4
- Distribution
- US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
- Location
- Shanghai, N/A
Frequently Asked Questions
What product was recalled? ▼
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended 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).. Recalled by Shanghai United Imaging Healthcare Co., Ltd.. Units affected: 4.
Why was this product recalled? ▼
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 5, 2020. Severity: Moderate. Recall number: Z-2704-2020.
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