GE Centricity PACS Image Storage Failure When Maximum Identifiers Reached
GE Healthcare Centricity PACS versions V2-V7 may fail to store medical images when reaching maximum unique image identifiers, potentially resulting in incomplete imaging studies. No injuries have been reported.
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 without reported hospitalizations, illnesses, or injuries. The hazard is a system malfunction that prevents complete image acquisition, representing a functional failure with potential patient care impact, but no actual harm has been documented.
Plain-English summary
GE Healthcare Centricity PACS (Picture Archiving and Communication System) versions V2, V3, V4, V6, and V7 are subject to this recall. The system is designed to manage and store radiological imaging data using unique image identifiers, known as Ckeys.
When Centricity PACS reaches its maximum number of unique image identifiers, the system cannot store additional medical images. This limitation prevents the completion of imaging studies, resulting in partial or incomplete study acquisitions. The condition affects the system's core function of reliably storing diagnostic imaging data.
The issue affects 2,138 units distributed worldwide across multiple healthcare facilities. GE Healthcare is working to address this limitation. Healthcare facilities using these affected software versions should contact GE Healthcare for product updates and remediation options to ensure complete image acquisition and system functionality.
The recalled product
- Product
- GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system.
- Manufacturer
- GE Healthcare
- Hazard
- storage-failure
- incomplete-data-acquisition
- system-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)
- All versions of Centricity PACS: V2
- UDI/DI Not Applicable
- V3
- V4
- UDI/DI 00840682124430
- V6
- UDI/DI 00840682104807
- V7
- UDI/DI 00840682145572 installed on the following systems: CARTI02312611
- CARTI22214087T
- 501268SSASW
- 501268SSATSW
- 928757VPASW
- 928757VPBSW
- 928757VPTSW
- 602344PVSW2
- 602344REPSITEB
- MARICOPAC02308029
- 602344TIMSVM
- 480323PVSW
Distribution
Distribution scope not specified by the agency.
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