GE Centricity Laboratory System Software Recall for Calculation Errors
GE Healthcare is recalling Centricity Laboratory System software due to a defect that may report calculated results as 0 or truncate them.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
GE Healthcare is recalling the Centricity Laboratory System software, an information system used to support clinical and administrative activities in laboratory facilities. The recall involves software versions 3.3, 4.0, and 4.1.
The recall is due to a potential safety issue where calculated results greater than 6 digits plus a decimal may be reported as 0 instead of 'TOO BIG' if significant figures are not defined, or may be truncated. This defect could affect the accuracy of analytical results stored and delivered by the system.
The affected units were distributed worldwide, including in the United States (Minnesota, Georgia, and California) and England. A total of 7 units are involved. Users of the Centricity Laboratory System should contact GE Healthcare for further instructions on how to address this software defect.
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
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