device · product 1 of 1
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).
- Recall number
- Z-2641-2020
- Initiated
- May 23, 2020
- Classification
- Class II
- Status
- Ongoing
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 3
App-derived interpretation
Unknown
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.
Official device-enrichment evidence · Sourced
Software design
Inspect official wording and provenance
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.
Code information
Serial Numbers: 353020, 353021, and 353023 with software version R001.11.0.729741-Re-1100
Distribution pattern
US Distribution to state of: TX