Computed Tomography X-ray System; Model uCT 550; Rx; UDI: (01) GTIN: 06971576831036 - 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).
FDA Recall Z-2705-2020 · Posted 2020-07-27
Recalling FirmShanghai United Imaging Healthcare Co., Ltd.
Recall StatusOpen, Classified
Product CodeJAK
Date Initiated2020-06-20
Product Quantity3
Reason for Recall
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.