Positron Emission Tomography and Computed Tomography recall
Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by…
Why was Positron Emission Tomography and Computed Tomography recalled?
A potential issue of an incorrect CT scan delay timer to be displayed on the gantry Digital Display Panel (DDP) during multi-phase contrast scanning. This could lead the operator to receive unnecessary exposure to radiation.
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: 200017, 200023, 200024, 200036, 200045, 200047, 230002, 230003, 230004
- Product
- Positron Emission Tomography and Computed Tomography System, Model uMI 550, Rx, CE, GTIN: 06971576832026 - Product Usage: intended to be operated by…
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 9
- Distribution
- US Nationwide distribution including in the state of TX.
- Recall date
- November 18, 2020
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)