GE Healthcare Recalls Centricity PACS Software Due to Data Association Errors
GE Healthcare is recalling Centricity PACS 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 software) where the hazard is misdiagnosis or delayed care, but no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm.
Plain-English summary
GE Healthcare is recalling Centricity PACS software, versions 2, 3, 4, 6, and 7. This software is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
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, which could lead to misdiagnosis or a delay in patient care.
The recall affects 1,443 systems distributed worldwide and nationwide in the US. Healthcare facilities using this software should contact GE Healthcare for instructions on how to resolve the issue and ensure patient data integrity.
The recalled product
- Product
- Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
- Manufacturer
- GE Healthcare
- Affected units
- 1,443
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 (3)
- UDI-DI: V4 - 00840682124430
- V6 - 00840682104807
- V7 - 00840682145572
Distribution
Distributed nationwide across the United States.
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