Computed Tomography X-ray System recall
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…
Why was 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?
Serial Numbers: 353020, 353021, and 353023 with software version R001.11.0.729741-Re-1100
- 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…
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 3
- Distribution
- US Distribution to state of: TX
- Recall date
- July 29, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)