Recall Z-2522-2020— Shanghai United Imaging Healthcare Co., Ltd.
Class II · Terminated
Class II FDA medical device recall by Shanghai United Imaging Healthcare Co., Ltd., initiated 2020-05-08, terminated 2022-01-20. It names one FDA 510(k) clearance: K172135. Product: uCT 760 System, Computed Tomography X-ray System. Reason: 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..
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-05-08
- Terminated
- 2022-01-20
- Firm location
- Shanghai, China
510(k) clearances named in this recall
1 on FDA's recordK-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
uCT 760 System, Computed Tomography X-ray System
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.