The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2469-2015·Announced 2015-09-02

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.

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, 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…
Manufacturer
GE Healthcare
Category
Medical Device — Imaging Software
Hazard
Affected units
82

Distribution

Distributed nationwide across the United States.

The notice also names 12 states specifically:

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.

See all 2 products in this recall →

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