GE Centricity Laboratory Software Recalled for Panel Reflex Failure
GE Healthcare is recalling Centricity Laboratory System software versions 3.3, 4.0, and 4.1 because panel reflexing may fail under specific conditions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could impact clinical workflow and patient care (risk-of-harm product), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
GE Healthcare is recalling the Centricity Laboratory System, a software information system designed to support clinical and administrative laboratory activities. The recall affects software versions 3.3, 4.0, and 4.1. The system is intended for use in laboratory facilities to manage order entry, results entry, and reporting, and is not intended for direct patient contact.
The recall is due to a potential safety issue where panel reflexing fails to occur if the DIP.Specimen field is blank and ad-hoc re-routing functionality is used. This failure specifically occurs when the ordered panel is a slave panel and the panitem specimen group field of one or more ordered items meets certain conditions. The source text does not report any specific illnesses, injuries, or deaths associated with this software defect.
The affected units were distributed worldwide, including nationwide in the United States (specifically noting Georgia) and internationally to Canada and the United Kingdom. A total of 7 units are listed in the structured product information. Users of the Centricity Laboratory System should contact GE Healthcare for further instructions regarding this software update or replacement.
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
- Affected units
- 7
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
- 4.1
Distribution
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