Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray Sy

FDA device recall Z-2641-2020 · posted 2020-07-20 · Open, Classified

Recall details

Recalling firm

Shanghai United Imaging Healthcare Co., Ltd.

Reason for recall

Two issues were identified with the computed tomography x-ray system including a service function which may cause false marking of a bad channel resulting in ring artifacts, and potential intermittent scout scanning interruption due to occasional angle signal drift.. If these problems occur, it may be necessary to rescan the patient resulting in an additional dose of radiation and the possible need for additional contrast medium.

Action taken

On 05/23/2020, Customer Notification Letters dated 5/22/2020 were emailed to customers. Customers were asked to do the following: For safety issue 1: If you observe image artifacts, please reboot the system and continue the reconstruction. If the image artifacts persist, please contact the recalling firm's service support team or call the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). For safety issue 2: If the scout scanning is interrupted, try repeating the scout scanning. If problem persists, please contact the recalling firm's service support team or call the Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). Customers were asked to notify all users of the affected products via Customer Notification Letter. On 8/30/2024, a correction notice was sent identifying an additional serial number.

Root cause

Software design

Status

Open, Classified

Product code

JAK

Quantity affected

3

Distribution

US Distribution to state of: TX

Date initiated

2020-05-23

Date posted

2020-07-20

Location

Shanghai, China

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