The Recall Desk
ModerateFDA (Devices)·Z-2593-2021·Announced 2021-10-06

uMI 550 PET Imaging System Software Workflow May Occasionally Freeze

The uMI 550 medical imaging system may occasionally freeze during the EXAM acquisition workflow when a PET scan is canceled. This can disrupt clinical operations.

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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a software operational defect (occasional freezing) without documented patient harm. This meets Score 2 criteria as a precautionary recall addressing a device workflow issue.

Plain-English summary

The uMI 550 System is a medical imaging device used by qualified healthcare professionals in clinical facilities to perform PET scans and assist in detecting, localizing, diagnosing, staging, and monitoring diseases in oncology, cardiology, and neurology. The device may occasionally freeze during the EXAM acquisition workflow when a user cancels an active PET scan.

This software defect could disrupt clinical workflow and delay patient diagnostic imaging services. A total of 23 systems with this condition were distributed across five U.S. states: California, Illinois, Indiana, Texas, and Wisconsin.

Healthcare facilities operating the affected uMI 550 System should contact the manufacturer, Shanghai United Imaging Healthcare Co., Ltd., for software updates or remediation guidance. The FDA has classified this as a Class II recall.

The recalled product

Product
uMI 550 System - Product Usage: intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, c
Manufacturer
Shanghai United Imaging Healthcare Co., Ltd.
Category
Medical Device — Diagnostic Imaging
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)

  • 200023
  • 200024
  • 200036
  • 200045
  • 200047
  • 230002
  • 230003
  • 230004
  • 200059
  • 230005
  • 230006
  • 230007
  • 230008
  • 230009
  • 230010
  • 230011
  • 230012
  • 230013
  • 230014
  • 230015

Distribution

Distributed nationwide across the United States.

The notice also names 5 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Shanghai United Imaging Healthcare Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Shanghai United Imaging Healthcare Co., Ltd.

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Same hazard · software freeze

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