FDA recall record

Spacelabs Healthcare Multi-parameter Command Module, Model 91496, optioned with Masimo or recall — FDA Z-1793-2026

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…

Class IIclassification
Z-1793-2026official record ID
Apr 15, 2026report date

Recall record at a glance

Official recordZ-1793-2026
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmSpacelabs Healthcare, Inc.
Report dateApr 15, 2026
Recall initiation dateFeb 27, 2026
Quantity1790
LocationSnoqualmie, WA, United States

Official product description

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

Why the product 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.

Distribution information

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.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

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About this record

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