GE Healthcare Recalls Centricity PACS-IW Due to Image Data Loss Risk
GE Healthcare is recalling 569 units of Centricity PACS-IW because a database error may cause image series to be missing from exams without user notification.
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. The hazard involves potential data integrity issues (missing images) rather than direct physical injury or death, and no illnesses or injuries are reported in the source text.
Plain-English summary
GE Healthcare is recalling 569 units of the Centricity PACS-IW medical device, specifically model numbers 2052831-00X and 2049588-008. The device is used to receive, store, communicate, process, and display medical images and data, including mammograms, from various imaging sources.
The recall is due to a potential database handling error that could occur during the image acquisition process. This error may result in one or more image series being missing from an exam without any indication to the user. The source notes that while this issue is rare, it can occur with imaging studies that consist of a very small number of images per series, such as a CR Thorax exam with only one image per series.
The affected units were distributed worldwide and across the United States. No specific dates or additional distribution details are provided in the source text. Users should check their device model and serial numbers against the recall list to determine if their unit is affected.
The recalled product
- Product
- GE Healthcare Centricity PACS-IW, Model Numbers: (a) 2052831-00X (b) 2049588-008 Product Usage: Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored…
- Manufacturer
- GE Healthcare
- Affected units
- 569
Distribution
Distributed nationwide across the United States.
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Similar recalls
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FDA (Devices) · 2015-10-14
- HighGE Healthcare Recalls Centricity PACS-IW Medical Image Viewer
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- HighGE Centricity PACS-IW Software Recall for Patient Safety Risks
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