The Recall Desk
ModerateFDA (Devices)·Z-0731-2014·Announced 2014-01-22

GE Centricity PACS System Recalled for Potential Image Loss During Transfer

GE Healthcare is recalling Centricity PACS System versions 3.X and 4.X due to a potential loss of diagnostic images during transfers between servers.

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, but the source text does not report any hospitalizations or significant injuries, and the hazard is a technical data loss issue rather than a direct physical injury risk.

Plain-English summary

GE Healthcare is recalling Centricity PACS System versions 3.X and higher and 4.X and higher. The recall involves 748 units distributed worldwide, including nationwide in the United States and in various foreign countries. The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals.

The recall is due to a potential loss of images associated with the Centricity to Centricity (C2C) exam transfer module. When transferring images from a source to a destination server, the transfer process may be terminated if another process in the destination server attempts to access the same object or table. This can result in the loss of specific diagnostic images.

Healthcare facilities using the affected software versions should contact GE Healthcare for instructions on how to resolve the issue. The source text does not report any specific illnesses or injuries associated with this recall.

The recalled product

Product
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: 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, technolo
Manufacturer
Ge Healthcare It
Category
Medical Device — Software
Hazard
Affected units
748

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)

  • GE Centricity Software versions 3.X and higher and 4.X and higher

Distribution

Distributed nationwide across the United States.

The notice also names 46 states specifically:

Related recalls

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Same hazard · data loss

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