GE Healthcare Recalls Centricity PACS Foundation Software
GE Healthcare is recalling Centricity PACS Foundation software because it may allow users to view incorrect patient images from external archives.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 incorrect patient data could lead to misdiagnosis, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
GE Healthcare, LLC is recalling 92 units of Centricity PACS Foundation software, including versions 6.0 SP9, 6.0 SP9.0.1, and 6.0 SP9.0.1.5. The 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 due to a defect where the updated series or study is not present in the archive. This creates a possibility that users may view studies directly from the Enterprise Archive or VNA with incorrect patient images.
The affected software was distributed worldwide, including nationwide in the United States and in 14 other countries. Healthcare facilities and users of the software should contact GE Healthcare for further instructions on how to resolve the issue.
The recalled product
- Product
- Centricity PACS Foundation Centricity PACS 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.
- Manufacturer
- GE Healthcare, LLC
- Category
- Medical Device — Software
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 (2)
- UDI # 840682104807 Model # 2098268-001 Software Version CPACS 6.0 SP9
- CPACS 6.0 SP9.0.1 and CPACS 6.0 SP9.0.1.5
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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