Computed Tomography X-ray System; Model uCT 760; Rx; UDI: (01) GTIN: 06971576831043 - 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-2703-2020
- Quantity
- 5 units
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 600229, 600230, 600232, 600271, 600282
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.
More recalls by Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomogra...
Apr 7, 2023
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to ass...
Aug 2, 2021