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.
- Hazard
- software-freeze
- workflow-malfunction
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.
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