The Recall Desk
ModerateFDA (Devices)·Z-1665-2014·Announced 2014-06-04

GE Healthcare Recalls Centricity PACS Workstation Due to Image Rejection Error

GE Healthcare is recalling 297 Centricity PACS Workstations because a software defect may cause images from previously displayed studies to be rejected unintentionally.

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 health consequences. The defect involves a software error in image management rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity recall.

Plain-English summary

GE Healthcare is recalling 297 units of the Centricity PACS Workstation. This medical device 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 used as a clinical review workstation throughout healthcare facilities.

The recall was initiated because a defect was identified in the reject image workflow. When multiple studies are simultaneously opened on the Centricity PACS RA1000 workstation and images are rejected from the active displayed study, images for a previously displayed study that remains open in the background may also be rejected. This issue can occur if one or more, but not all, images in the background study are affected.

The affected units were distributed worldwide, including nationwide in the United States and in numerous international countries such as Australia, Canada, France, Germany, India, Japan, and the United Kingdom. The recall covers specific versions of the Centricity PACS software, including versions 3.2, 4.0, and various service packs. Healthcare facilities should contact GE Healthcare for instructions on how to resolve this issue.

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 professional, including radiologists, physicians, technologists, clinicians, and nurses. It is also intended for use as a clinical review work
Manufacturer
GE Healthcare
Category
Medical Device — Imaging Software
Hazard
Affected units
297

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 (14)

  • Centricity PACS versions: 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
  • 3.2 SP7
  • 3.2 SP8
  • 4.0
  • 4.0.1
  • 4.0 SP3

Distribution

Distributed nationwide across the United States.

The notice also names 42 states specifically:

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