The Recall Desk
ModerateFDA (Devices)·Z-1585-2013·Announced 2013-07-03

GE Healthcare Recalls Centricity Laboratory System Software Due to Data Loss

GE Healthcare is recalling 9 units of Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because a specific configuration can cause loss of free-text data in microbiology results.

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 integrity issues (loss of free-text) rather than direct physical injury or death, fitting the criteria for moderate severity where the risk is significant but not immediately life-threatening.

Plain-English summary

GE Healthcare is recalling 9 units of the Centricity Laboratory System, a software application used to support clinical and administrative activities in laboratory facilities. The recall affects software versions 3.3, 4.0, and 4.1. The system is intended for use in central or multiple laboratory environments and is not intended for direct patient contact.

The recall is due to a software defect where, if specific environment variables (MICRO_CORRECT_MSG_TYPE and CORRECT_MSG_TYPE) are set to different values, some originally entered panel free-text may be lost. This issue occurs when released microbiology results are changed and the corrected result messages are edited on the free-text form.

The affected units were distributed worldwide, including in the United States (Ohio, New York, Georgia, Texas, Tennessee, and Minnesota) and in Australia, Qatar, and England. Users of the Centricity Laboratory System should check their software version and environment variable configurations to determine if they are affected.

The recalled product

Product
The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical res
Manufacturer
GE Healthcare It
Category
Medical Device — Laboratory Software
Hazard
Affected units
9

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 (3)

  • Software Versions 3.3
  • 4.0
  • and 4.1

Distribution

Distributed in 6 states:

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