uCT 530 Computed Tomography X-Ray System recall
uCT 530 Computed Tomography X-Ray System
Why was uCT 530 Computed Tomography X-Ray System recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Units with software version no. R001.11.0.729741-Re-1100 including the following: Serial number/GTIN: 300162 (GTIN: 6971576831012); 300163 (GTIN: 6971576831012); 300174 (GTIN: 6971576831012); and 300176 (GTIN: 6971576831012).
- Product
- uCT 530 Computed Tomography X-Ray System
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 4 units
- Distribution
- Distributed to Texas.
- Recall date
- July 8, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)