MEDITECH Expanse laboratory software data loss with simultaneous inputs
The MEDITECH Expanse Laboratory system may lose data from the first field when multiple keys are pressed simultaneously. Install the latest software update to resolve this issue.
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: This is an FDA Class II medical device with potential for data loss in clinical laboratory systems. While no illnesses or injuries have been reported, the risk of losing clinical laboratory data constitutes a risk-of-harm scenario that warrants a High severity rating.
Plain-English summary
The MEDITECH Expanse Laboratory system, used for clinical laboratory testing including microbiology, anatomical pathology, and genetics analysis, has a software vulnerability that may cause data loss.
When users press multiple keys that trigger input simultaneously, data in the first field of screens and questionnaires with multiple fields may be removed. This affects approximately 148 units deployed worldwide, including locations in the United States, British Virgin Islands, Canada, Ireland, and the United Kingdom.
The vulnerability affects software release versions 2.1 and 2.2 using the Web Presentation Layer. Medical Information Technology, Inc. is recalling the affected software versions to prevent potential data loss in clinical laboratory records.
Affected laboratory facilities should obtain and install the corrected software version immediately to ensure accurate data capture and prevent loss of clinical test data.
The recalled product
- Product
- MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data processing module for clinical use.
- Manufacturer
- Medical Information Technology, Inc.
- Hazard
- data-loss
- concurrent-input-error
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 Release: 2.1
- 2.2 (using the Web Presentation Layer)
- UDI: 00863529000155.
Distribution
Distributed nationwide across the United States.
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