GE Healthcare Recalls Centricity PACS Web Diagnostic Software
GE Healthcare is recalling 118 units of Centricity PACS Web Diagnostic software due to a defect where study category labels and hanging positions appear incorrectly swapped.
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 2/5 (Moderate).
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: The recall is classified as FDA Class II, and the defect involves a software display error (swapped labels/positions) without reported injuries or illnesses, fitting the criteria for a moderate severity issue.
Plain-English summary
GE Medical Systems Information T is recalling 118 units of Centricity PACS Web Diagnostic (WebDX) software. The affected versions are 1.0, 1.1, 2.0, and 2.1. This software is used to receive medical images, including mammograms, and data from various imaging sources within a system or across computer networks.
The recall was initiated after a complaint reported that study category labels, specifically "Prior" and "Baseline," and hanging positions appeared incorrectly swapped. This error occurs when the hanging protocol for three comparison studies is manually applied from the patient folder. The product was distributed nationwide and worldwide.
Healthcare facilities using this software should contact GE Healthcare for instructions on how to resolve the issue. The defect involves the incorrect display of image labels and positions, which could lead to confusion during the review of medical images.
The recalled product
- Product
- Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
- Manufacturer
- Ge Medical Systems Information T
- Category
- Medical Device — Software
- Affected units
- 118
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 (4)
- Versions 1.0
- 1.1
- 2.0
- 2.1
Distribution
Distributed nationwide across the United States.
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