Computed Tomography X-ray System recall
Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the…
Why was Computed Tomography X-ray System recalled?
The metal edge overlap of the mylar strip in the gantry was uneven, which may create a sharp edge.
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?
SN 300162, 300163, 300174, 300176
- Product
- Computed Tomography X-ray System; Model uCT 530; Rx; UDI: (01) GTIN: 06971576831012 - Product Usage: intended to produce cross-sectional images of the…
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 4
- Distribution
- US Nationwide distribution including in the states of CA, IN and TX. See uploaded distribution list for more details.
- Recall date
- August 5, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)