The Recall Desk
ModerateFDA (Devices)·Z-3282-2026·Announced 2026-10-07

United Imaging CT System Recall Due to Software Image Visibility Issue

Shanghai United Imaging Healthcare is recalling 53 uCT ATLAS Astound CT systems due to a software defect that may hide patient images, potentially requiring rescans.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text explicitly states no injuries or illnesses have been reported, and the hazard is limited to the potential need for rescans rather than direct physical harm.

Plain-English summary

Shanghai United Imaging Healthcare Co., Ltd. is recalling 53 units of the Computed Tomography X-ray System, Model: uCT ATLAS Astound with software. The recall is due to a software problem that occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study. In these specific conditions, patient images may not be visible on the Patient Administration interface.

The affected units were distributed nationwide in the United States, including in California, Puerto Rico, Utah, West Virginia, North Dakota, Nebraska, North Carolina, Texas, Idaho, Louisiana, Montana, Florida, Colorado, Indiana, Kentucky, Alabama, Ohio, Michigan, Iowa, Missouri, New York, Nevada, Tennessee, South Carolina, Wisconsin, Illinois, Mississippi, Massachusetts, and New Jersey. The recall number is Z-3282-2026.

The primary risk associated with this defect is that the inability to view patient images may result in the need for rescans. No injuries or illnesses have been reported in connection with this recall. Healthcare facilities should contact the manufacturer for instructions on how to resolve the software issue.

The recalled product

Product
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
53

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 803012/R002.4.6.1607336-Re3100SP4
  • 803013/R002.4.6.1607336-Re3100SP4
  • 803014/R002.9.0.1897081-Re3310SP1
  • 803016/R002.4.6.1607336-Re3100SP4
  • 803017/R002.9.0.1897081-Re3310SP1
  • 803018/R002.9.0.1897081-Re3310SP1
  • 803019/R002.4.6.1607336-Re3100SP4
  • 803020/R002.9.0.1897081-Re3310SP1
  • 803022/R002.9.0.1897081-Re3310SP1
  • 803023/R002.9.0.1897081-Re3310SP1
  • 803024/R002.9.0.1897081-Re3310SP1
  • 809001/R002.8.1.1840891-Re3310A_P1
  • 809002/R002.9.0.1897081-Re3310SP1
  • 809003/R002.8.1.1840891-Re3310A_P1
  • 809004/R002.4.6.1607336-Re3100SP4
  • 809005/R002.4.6.1607336-Re3100SP4
  • 809006/R002.8.1.1840891-Re3310A_P1
  • 809007/R002.4.7.1671762-Re3100SP4_P1
  • 809008/R002.4.7.1671762-Re3100SP4_P1
  • 809009/R002.4.7.1671762-Re3100SP4_P1

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

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