uDR uDR 596iRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

2 FDA recall records name this device's identifier.

1 other recall cover devices cleared under the same FDA submission (K181413, K192293); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Feb 27, 2020Terminated

   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.

   Z-2521-2020 · Root cause: Software design · FDA record ↗

2. Jul 30, 2019Terminated

   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.

   Z-1075-2022 · Root cause: Software change control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K181413, K192293. One submission often covers many models, so check the product and lot details in each record.

• Z-1160-2021 · Jan 25, 2021 · Terminated
  Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both a