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).
- Company
- Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
- Recall Initiated
- June 20, 2020
- Posted
- July 27, 2020
- Recall Number
- Z-2704-2020
- Quantity
- 4
Reason for Recall
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Distribution
US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Lot / Code Info
SN 300162, 300163, 300174, 300176
Root Cause
Device Design
Action Taken
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.
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