The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0023-2016·Announced 2015-10-14

GE Healthcare Recalls Centricity PACS IW Due to Missing Images

GE Healthcare is recalling 921 Centricity PACS IW systems worldwide because 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, and the hazard involves a software defect that may result in missing images without reported injuries or fatalities, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

GE Healthcare is recalling 921 units of the Centricity PACS IW device, a system used to receive, store, communicate, process, and display medical images and data, including mammograms. The recall covers versions 3.5.0 through 3.7.3.9 Sp2, 3.7.3 Spa10, and 4.0.1.

The recall was initiated because images may be missing when a system parameter named 'MapRoute' is set to a value greater than 1. This defect affects the integrity of the medical imaging data processed by the device.

The affected systems were distributed worldwide, including nationwide in the United States and in numerous international countries. Healthcare facilities using these systems should contact GE Healthcare for further instructions on how to address the issue.

The recalled product

Product
Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks…
Manufacturer
GE Healthcare
Category
Medical Device — Medical Imaging Software
Hazard
Affected units
921

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 (3)

  • GE Centricity PACS-IW versions 3.5.0 through 3.7.3.9 Sp2
  • 3.7.3 Spa10
  • and 4.0.1

Distribution

Distributed nationwide across the United States.

The notice also names 49 states specifically:

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