Recall Z-2641-2020— Shanghai United Imaging Healthcare Co., Ltd.

Name: FDA recall Z-2641-2020
Creator: U.S. Food and Drug Administration
Published: 2020-05-23

Class II · Ongoing

Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2020-05-23. It names one FDA 510(k) clearance: K181414. Product: Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).. Reason: 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..

Recalling firm: Shanghai United Imaging Healthcare Co., Ltd.
Classification: Class II
Status: Ongoing
Initiated: 2020-05-23
Firm location: Shanghai, N/A, China

510(k) clearances named in this recall

1 on FDA's record

K181414 — uCT 530, uCT 550Shanghai United Imaging Healthcare Co., Ltd.·cleared 2018-08-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Computed Tomography X-ray System, Model: uCT 550, GTIN: 06971576831036 Intended use The uCT Computed Tomography X-ray System uCT 530/uCT 550 is a computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes and indicated for the whole body (including head, neck and vascular).

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.