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).
Recall
- Recall Number
- Z-2704-2020
- Event Number
- 85868
- Firm
- Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
- FEI Number
- 3011015597
- Product Code
- JAK
- Status
- Open, Classified
- Root Cause
- Device Design
- Initiated
- June 20, 2020
- Posted
- July 27, 2020
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).
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
A Customer Notification Letter was sent to the affected consignees on 06/20/2020 via email. United Imaging will replace the mylar strip with an improved one on the affected products via on-site update. On 8/30/2024, a correction notice was sent identifying an additional serial number.
US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
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