Spacelabs Healthcare Model 91496 cardiac monitor recalled for inaccurate heart output readings
What this means
Certain Spacelabs Healthcare Model 91496 multi-parameter cardiac monitors have a circuit board defect. When the device is in Auto mode, the cardiac output measurement may start too early, causing errors that prevent proper readings or exclude readings that should be included. This could lead to inaccurate patient information and delayed medical decisions.
- Check if your Model 91496 serial number matches the FDA recall list
- Contact Spacelabs Healthcare or your equipment supplier for guidance
- Do not rely solely on Auto mode cardiac output readings until you receive further instruction
- Continue to manually verify readings using alternative methods as appropriate
The agency's original wording
Multi-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad Curve error with no CO measurement or Irregular Curve error with CO measurement not automatically excluded, which may result in inaccurate readings, or the need of additional readings, which may lead to delayed care and/or fluid overload.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1793-2026Want us to check the next one for you?
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