Spacelabs Healthcare Recalls Pathfinder SL Holter Analyzer Software
Spacelabs Healthcare is recalling Pathfinder SL software due to crashes and incorrect QTc values. The software is used to analyze Holter monitor data.
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 software malfunction and data inaccuracy without reported injuries or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Spacelabs Healthcare, LLC is recalling 114 units of Pathfinder SL software, version 1.6.0.3057, used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer. The software is used to analyze information collected from ambulatory electrocardiogram recorders worn by patients to assist physicians in diagnosis and patient monitoring.
The recall was initiated because the software crashes with an error message after editing a batch of Holter Analyzer records, requiring a restart. Additionally, QTc values, which are timing events in the ECG signal, do not update correctly after moving the cursor marker.
The affected software was distributed worldwide, including the United States (nationwide, specifically noting Nevada and Vermont), Australia, Austria, Canada, Cyprus, Germany, Iceland, Israel, Poland, Romania, South Africa, Switzerland, Thailand, Turkey, and the United Kingdom. Users should contact Spacelabs Healthcare for further instructions.
The recalled product
- Product
- The product is Pathfinder SL, version 1.6.0.3057 software used with the Spacelabs Healthcare Pathfinder SL Holter Analyzer, version 1.6.0. Product Usage: The Holter Analyzer analyzes information collected from ambulatory electrocardiogram recorders worn by patients and used t
- Manufacturer
- Spacelabs Healthcare, Llc
- Affected units
- 114
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 (1)
- Version 1.6.0.
Distribution
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