GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors
GE Healthcare is recalling Centricity Enterprise Archive software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.
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 imaging software) where injury (misdiagnosis or delayed care) has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
GE Healthcare is recalling Centricity Enterprise Archive V2, V3, and V4 software, which is used for receiving, archiving, and sending electronic medical data. The recall affects 1,856 systems distributed worldwide and across the United States.
The recall is 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.
Healthcare facilities using the affected software should contact GE Healthcare for further instructions on how to address the data association issue.
The recalled product
- Product
- Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
- Manufacturer
- GE Healthcare
- Affected units
- 1,856
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 (1)
- UDI-DI: V4 - 00840682102766
Distribution
Distributed nationwide across the United States.
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