The Recall Desk
ModerateFDA (Devices)·Z-2739-2016·Announced 2016-09-14

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

GE Healthcare is recalling Centricity Enterprise Archive software version 3.0.x due to a potential for data loss when the cache disk is nearly full.

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 involves data loss in a specific, unlikely technical scenario (cache disk <100MB) without reported injuries or deaths, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

GE Healthcare It is recalling 1,379 units of Centricity Enterprise Archive software, version 3.0.x. This software is used for receiving, archiving, and sending medical data and is distributed nationwide. The recall is due to a potential for data loss associated with empty path names resulting from HL-7 updates when the cache disk is almost full.

The issue occurs in an unlikely event where the cache disk is almost full (less than 100MB) and HL-7 update events are received. In this scenario, the update action fails, and an empty path name is written to the database. As a result, the medical data instance is not deleted from the storage device but is no longer referenced, causing an error when attempting to retrieve the instance.

Qualified system administrators who install, monitor, and maintain the system are the intended users. The source text does not specify specific consumer actions or contact information for resolution.

The recalled product

Product
Centricity Enterprise Archive is a software product for receiving, archiving and sending of medical data. Qualified system administrators install, monitor and maintain the system. DICOM devices (e.g. modalities, workstations) communicate with the archive using the DICOM protocol
Manufacturer
Ge Healthcare It
Hazard
Affected units
1,379

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)

  • Version: 3.0.x

Distribution

Distributed nationwide across the United States.