Shanghai United Imaging Healthcare Co., Ltd. No. 2258 Chengbei Rd, Jiading Ind. Shanghai China uCT 530 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 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.

Recommended Action

Per FDA guidance

The firm sent letters to their customers by email on 5-22-2020. The letter informs customers of the two potential safety issues with the device, and notes that these problems may cause image artifacts and scanning workflow interruptions. Risks to patient health are noted to include the possible need to rescan the patient resulting in an additional radiation dose and the possible need for additional contrast medium. Customers were informed that United Imaging has released a field update for the uCT 530 to address the issues. If customers observe image artifacts, they are requested to reboot the system and continue the reconstruction. If the scout scanning is interrupted, customers are instructed to try repeating the scout scanning. If problems persist, customers should 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).

Distribution

As reported by FDA

TX