Shanghai United Imaging Healthcare Co., Ltd. recalls Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
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…
Read the official notice →- Date
- 2022-05-18
- Country
- United States
- Brand
- Shanghai United Imaging Healthcare
- Product
- Digital Medical X-ray Imaging System, Model: uDR 596i, uDR 592h
- Classification
- Class II
- Units
- US Nationwide distribution in the state of TX.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
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