Digital Medical X-ray Imaging System recall
Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
Why was Digital Medical X-ray Imaging System recalled?
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
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?
DI/GTIN: 06971576833023, Serial Numbers: 270012, 270013,270014, 270015
- Product
- Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
- Recalling firm
- Shanghai United Imaging Healthcare Co., Ltd.
- Quantity
- 4
- Distribution
- US Nationwide distribution in the state of TX.
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)