The Recall Desk
ModerateFDA (Devices)·Z-3278-2026·Announced 2026-10-07

United Imaging uCT 550 CT Systems Recalled for Software Defect

Shanghai United Imaging Healthcare is recalling 23 uCT 550 CT systems due to a software issue 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, and the hazard involves a software defect that may lead to rescans rather than direct injury or death, fitting the criteria for a moderate severity level.

Plain-English summary

Shanghai United Imaging Healthcare Co., Ltd. is recalling 23 units of the Computed Tomography X-ray System, Model uCT 550, due to a software defect. The recall covers systems distributed nationwide in the United States, including specific states such as California, Texas, and New York.

The software issue occurs when the Split or Local function is enabled and multiple RIS exams are merged into a single study. This defect prevents patient images from being visible on the Patient Administration interface. As a result, healthcare facilities may need to perform rescans of patients to obtain the necessary images.

Healthcare facilities should contact Shanghai United Imaging Healthcare Co., Ltd. for instructions on how to resolve the software issue. The recall is classified as Class II by the FDA, indicating that the defect may cause temporary or medically reversible health consequences.

The recalled product

Product
Computed Tomography X-ray System, Model: uCT 550 with software
Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.
Category
Medical Device — Imaging Equipment
Hazard
Affected units
23

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)

  • 353045/R001.19.6.1857994-Re3300SP1H1_P5
  • 353049/R001.19.6.1857994-Re3300SP1H1_P5
  • 354001/R001.19.6.1857994-Re3300SP1H1_P5
  • 354004/R001.19.6.1857994-Re3300SP1H1_P5
  • 354005/R001.19.6.1857994-Re3300SP1H1_P5
  • 354007/R001.19.6.1857994-Re3300SP1H1_P5
  • 354009/R001.19.6.1857994-Re3300SP1H1_P5
  • 354013/R001.19.6.1857994-Re3300SP1H1_P5
  • 354015/R001.19.6.1857994-Re3300SP1H1_P5
  • 354016/R001.19.6.1857994-Re3300SP1H1_P5
  • 354018/R001.17.6.1607336-Re3100SP4
  • 354020/R001.17.6.1607336-Re3100SP4
  • 354021/R001.17.6.1607336-Re3100SP4
  • 354022/R001.19.4.1810621-Re3300SP1H1_P3
  • 354023/R001.19.6.1857994-Re3300SP1H1_P5
  • 354024/R001.19.6.1857994-Re3300SP1H1_P5
  • 354025/R001.19.6.1857994-Re3300SP1H1_P5
  • 354026/R001.19.6.1857994-Re3300SP1H1_P5
  • 354027/R001.19.6.1857994-Re3300SP1H1_P5
  • 354028/R001.19.6.1857994-Re3300SP1H1_P5

Distribution

Distributed nationwide across the United States.

The notice also names 29 states specifically:

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