GE Healthcare Recalls Workflow Core Services V8 Due to Data Association Errors
GE Healthcare is recalling Workflow Core Services V8 because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device software) where injury or misdiagnosis has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
GE Healthcare is recalling Workflow Core Services V8, a software system intended to provide services for the storage and retrieval of patient data and exams. The recall affects 169 systems distributed worldwide and across the United States.
The recall is being issued because, under certain conditions, historical imaging data migrated from a legacy system may become incorrectly associated with a different patient. If this occurs, studies or images may be displayed under the wrong patient record.
This error could lead to misdiagnosis or a delay in patient care. The source text does not specify specific actions for consumers or healthcare providers beyond the recall notice.
The recalled product
- Product
- Workflow Core Services V8, intended to provide set of services for storage and retrieval of patient data, exams and performs system Administration, common configuration management for consuming applications, All versions
- Manufacturer
- GE Healthcare
- Category
- Medical Device — Software
- Affected units
- 169
Distribution
Distributed nationwide across the United States.
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