Shanghai United Imaging Healthcare recalls uDR 596i X-Ray Systems with software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112 due to incorrect anatomical positioning and potential radiation exposure risks.
Two issues were identified with the stationary x-ray system. 1. Some position illustrations in the patient exam interface show the incorrect anatomical position for the standard of care. When the image is acquired with the wrong reference position, clinical diagnostic requirements cannot be met.T2. Where image stitching is used, the left and right tag information may be lost. When these problems are encountered, an additional exposure is needed and the patient will receive more radiation.
Shanghai United Imaging Healthcare is recalling uDR 596i X-Ray Systems because some position illustrations show incorrect anatomical positions, which can lead to misdiagnosis. Additionally, image stitching may cause loss of tag information, requiring extra radiation exposure for the patient.
The system's position illustrations sometimes show incorrect anatomical positions, which can lead to misdiagnosis if the image is acquired with the wrong reference. When image stitching is used, left and right tag information may be lost, requiring additional X-ray exposures and increasing radiation exposure for patients.
Qualified medical professionals who use the uDR 596i X-Ray Systems for diagnostic imaging are affected. Patients receiving scans with the recalled units may receive additional radiation exposure.
Check for model number uDR 596i with software versions R002.19.0-1.8402-690106 or R002.19.0.8648.690112. Serial numbers 270012-270017 are also affected.
Verify the software version on your uDR 596i system to see if it matches the affected versions R002.19.0-1.8402-690106 or R002.19.0.8648.690112.
Ensure the patient exam interface shows correct anatomical positioning for standard care procedures.
The recall is due to incorrect anatomical position illustrations in the patient exam interface that can lead to misdiagnosis, and potential loss of tag information during image stitching that may require additional radiation exposure.
Software versions R002.19.0-1.8402-690106 and R002.19.0.8648.690112 are affected.
Check for model number uDR 596i with the affected software versions or serial numbers 270012-270017.
We’ve drafted a message you can send Shanghai United Imaging Healthcare to request your refund or repair — edit it as you like.
Subject: Recall Z-2521-2020 — Shanghai United Imaging Healthcare Shanghai United Imaging Healthcare Hello, I own a Shanghai United Imaging Healthcare that is covered by recall Z-2521-2020 from Shanghai United Imaging Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
