GE Healthcare Recalls Centricity PACS-IW Systems Due to Missing Images
GE Healthcare is recalling 82 Centricity PACS-IW systems because medical images may be missing when a specific system parameter is set to a value greater than 1.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a software defect leading to missing images, which is a significant functional failure but does not involve direct physical injury or death.
Plain-English summary
GE Healthcare is recalling 82 units of the Centricity PACS-IW with Universal Viewer, a medical device used for the acceptance, transfer, display, storage, and digital processing of medical images. The recall covers systems running versions 5.0 through 5.0 SP7.
The recall was initiated because images may be missing when the system parameter MapRoute is set to a value greater than 1. This issue affects the reliability of the device's ability to display and process medical images.
The affected systems were distributed worldwide, including in the United States and various international locations. Users of these systems should contact GE Healthcare for instructions on how to resolve the issue.
The recalled product
- Product
- Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processin
- Manufacturer
- GE Healthcare
- Hazard
- Affected units
- 82
Distribution
Part of a larger recall action
This product is one of 2 recalled by GE Healthcare 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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