Digitial Medica X-ray Imagining System recall
Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained…
Why was Digitial Medica X-ray Imagining System recalled?
There is a potential for the X-Ray tube head (Touch screen interface) to perform an uncommanded motion. This could result in a collision with the patient.
What should I do if I have this product?
Review the official FDA enforcement record for current 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 Number: 270012, 270013, 270014, 270015, 270016, 270017
- Product
- Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained…
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the state of TX.
- Recall date
- March 10, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)