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FDA-Device2026-04-15Class IIPROCESSING DEFECT

Spacelabs Healthcare Model 91496 cardiac monitor recalled for inaccurate heart output readings

Spacelabs Healthcare
OTHERNationwide distribution

Contact Spacelabs about your Model 91496 monitor

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
Hazard

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.

Sold states
Worldwide - US Nationwide distribution including in the states of NY, NJ, AL, OK, IA, MT, WY, MN, TX, WI, PA, WA, OR, MI, CA, SC, ID, FL, MS, KS, SD, LA, OH, MO, NH, GA, MD, TN, AZ, PR and the countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA.
Affected count
1790
Manufactured in
35301 Se Center St, Snoqualmie, WA, United States
Products
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1793-2026

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