The Recall Desk
ModerateFDA (Devices)·Z-0833-2015·Announced 2014-12-31

GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk

GE Healthcare is recalling Centricity Enterprise Archive software versions 4.0.x due to a potential data loss issue associated with HL-7 updates.

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. The hazard is a potential data loss issue, which is a significant operational risk but does not involve direct physical injury or death, fitting the criteria for a moderate severity score.

Plain-English summary

GE Healthcare is recalling 115 units of Centricity Enterprise Archive software, versions 4.0.x. This software is used for receiving, archiving, and sending medical data and communicates with DICOM devices using the DICOM protocol. The recall is due to a potential data loss issue that can occur when the cache disk is almost full and HL-7 updates result in empty path names.

The affected software was distributed nationwide, including in Arizona, Ohio, and Washington. The intended users for Centricity Enterprise Archive are service personnel, system administrators, and non-clinical users. As of version 4.0, XDS-enabled systems can also communicate with the archive using XDS and XDS-1 profiles.

The source text does not provide specific instructions for consumers or affected users on how to proceed with the recall or remediation.

The recalled product

Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. DICOM devices (e..g. modalities, workstations) Communicate with the archive using the DICOM protocol (published by ACR-NEMA). The clinical use is limited to the interaction t
Manufacturer
Ge Healthcare It
Category
Medical Device — Software
Hazard
Affected units
115

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 Enterprise Archive versions: 4.0.x

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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