Medical device recalls Moderate risk

Spacelabs Healthcare, Inc. recalls Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

Recall date
February 27, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1793-2026
FDA classification
Class II
Brand / firm
Spacelabs Healthcare, Inc.
Sold / distributed
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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor

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