The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0116-2014·Announced 2013-11-06

GE Centricity PACS Workstation Recalled for Workflow Interruption Issues

GE Healthcare is recalling 623 Centricity PACS Workstations due to software workflow interruptions that may prevent exams from closing correctly in the system.

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, but the source text describes software workflow interruptions without reporting any hospitalizations, injuries, or deaths, fitting the criteria for a moderate severity score.

Plain-English summary

GE Healthcare is recalling 623 units of the Centricity PACS Workstation, a primary diagnostic and analysis tool used by healthcare professionals to display and manage diagnostic images. The recall affects specific versions of the software, including 3.1.1.2, 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 4.0, and 4.0.1.

The recall is due to potential issues associated with specific workflows in the Centricity PACS RA1000 workstation. In certain RIS-Driven integrations, the "close" button may close the exam in the RIS-IC system but fail to close it in the Centricity PACS RA1000 Workstation. Additionally, interrupted workflows could break the process, potentially leading to data management errors.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries such as the UK, Canada, Australia, and various nations in Europe, Asia, and the Middle East. Healthcare facilities using these workstations should contact GE Healthcare for instructions on how to resolve the software issues.

The recalled product

Product
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review…
Manufacturer
GE Healthcare It
Category
Medical Device — PACS Workstation
Hazard
Affected units
623

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 (12)

  • GE Centricity PACS Versions: 3.1.1.2
  • 3.2
  • 3.2.0.1
  • 3.2.0.2
  • 3.2.1
  • 3.2.2
  • 3.2.2.1
  • 3.2.2.2
  • 3.2.2.3
  • 3.2.6
  • 4.0
  • 4.0.1

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

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