Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China uCT 760 System, Computed Tomography X-ray System Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Two issues were identified with the computed tomography x-ray system including an intermittent issue which may affect image data leading to artifacts; and intermittent scout scanning interruption due to occasional angle signal drift. This may result in the need for rescanning of the patient with the patient receiving an additional dose of radiation and possible use of additional contrast media.

Recommended Action

Per FDA guidance

Customers were sent emails on 05/22/2020 notifying them of the failure modes and the potential safety issues. Customers were informed that If image artifacts occur, it may be necessary for the user to repeat the examination. The rescan of the patient will result in an additional dose and the possible need for additional contrast medium. Customers were also informed that if the scout scanning is unexpectedly interrupted, it may be necessary for the user to repeat the scout scanning, resulting in an additional dose. Customers observing image artifacts were instructed to reboot the system and continue the reconstruction, and, if image artifacts persist, to contact their United Imaging service support team or call the United Imaging Customer Contact Center at (855) 221-1552 (toll free) or (832) 699-2799 (direct). Similarly, if scout scanning is interrupted, customers were instructed to attempt repeating the scout and to contact the service support team if the problem continues. The email informs customers that United Imaging has released updated software R001.11.0.820958-Re-1150SP1+H1H2 to solve the intermittent issue and to eliminate angulation signal drift, which could eliminate the resulting image artifacts and scout scanning interruption, and to accomplish other improvements. Customers with further questions should contact the United Imaging Customer Contact Center at {855) 221-1552 {toll free) or {832) 699-2799 {direct).

Distribution

As reported by FDA

IN, TX