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).
Enforcement
- Recall Number
- Z-2641-2020
- Event ID
- 85771
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 29, 2020
- Initiation Date
- May 23, 2020
- Classification Date
- July 17, 2020
- Address
- No. 2258 Chengbei Rd, Jiading Ind., N/A, Shanghai, N/A, N/A, China
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).
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.
Serial Numbers: 353020, 353021, and 353023 with software version R001.11.0.729741-Re-1100
US Distribution to state of: TX
3