Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2579-2016·Announced 2016-08-24

GE Centricity PACS Workstation Recalled for Image Grouping Errors

GE Healthcare is recalling 498 Centricity PACS Workstations due to a software defect that causes random image-series grouping errors when specific exams are opened simultaneously.

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 corresponds to a moderate severity score. The defect causes image grouping errors, which is a functional software issue rather than a direct physical hazard like fire or shock, and no injuries or illnesses are reported in the source text.

Plain-English summary

GE Healthcare is recalling 498 units of the GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x. This Picture Archiving and Communication System is used by trained healthcare professionals, including radiologists, physicians, and technologists, as a primary diagnostic and analysis tool for diagnostic images.

The recall is due to a software defect that occurs when the middle tier is configured to the wrong IP address of the Centricity Exam Manager. When a current and historical exam are opened at the same time, the system asynchronously tries to access the operation specifying how each image should be grouped, resulting in random image-series grouping errors.

The affected units were distributed worldwide, including the US, Puerto Rico, Canada, and numerous countries in Europe, Asia, and the Middle East. Healthcare facilities using these workstations should contact GE Healthcare for instructions on how to resolve the issue.

The recalled product

Product: GE Centricity PACS Workstation, versions 3.1.1.x through 3.2.1.x Picture Archiving and Communication System Used as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists…
Manufacturer: GE Healthcare It
Category: Medical Device — Imaging Software
Hazard: software-defect
data-integrity
Affected units: 498

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 (1)

Centricity PACS versions 3.1.1.x through 3.2.1.x

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · GE Healthcare It

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