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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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…
- 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
Related recalls
Same manufacturer · GE Healthcare It
See all →- ModerateGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
FDA (Devices) · 2016-09-14
- HighGE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors
FDA (Devices) · 2016-09-07
- ModerateGE Centricity PACS Workstation Recalled for Image Grouping Errors
FDA (Devices) · 2016-08-24
- HighGe Healthcare Recalls Imagecast PACS Software Due to Image Context Defect
FDA (Devices) · 2016-08-03
- ModerateGE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Loss Risk
FDA (Devices) · 2014-12-31
Same hazard · software defect
See all →- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
- ModeratePhilips SmartPath to MR 7700 Recalled for Incorrect DTI Export Data
FDA (Devices) · 2026-10-07
Similar recalls
- HighGE Healthcare Recalls Centricity Laboratory Software Due to Data Deletion Errors
FDA (Devices) · 2016-09-07
- LowGE Centricity Laboratory System Software Recall for Calculation Errors
FDA (Devices) · 2014-02-05
- ModerateGE Healthcare Recalls Centricity Laboratory System Software Due to Data Loss
FDA (Devices) · 2013-07-03
- ModerateGE Centricity Laboratory System Recall for Free-Text Data Loss
FDA (Devices) · 2014-01-08
- ModerateGE Healthcare Recalls Centricity PACS Workstation Due to Exam Merge Failure
FDA (Devices) · 2015-03-04
- ModerateGE Centricity PACS System Recalled for Potential Image Loss During Transfer
FDA (Devices) · 2014-01-22