FDA recall Z-1793-2026

Spacelabs Healthcare, Inc. · Class II · device

Product

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

Reason for recall

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

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.

Key facts

Status
Ongoing
Initiation date
2026-02-27
Report date
2026-04-15
Voluntary/Mandated
Voluntary: Firm initiated
Location
Snoqualmie, WA, United States

Primary source

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