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

FDA device recall Z-1793-2026 · posted 2026-04-07 · Open, Classified

Recall details

Recalling firm

Spacelabs Healthcare, Inc.

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.

Action taken

On 2/27/2026, correction notices were emailed to customers who were asked to do the following: 1. Notify all relevant employees within your organization. If products were further distributed, please forward the notice to these sites/customers. 2. Complete and return the acknowledgement form via email to: Installedbase@Spacelabs.com 3. Instruct staff who utilize the cardiac output feature to use the "Manual" mode, or use a non-impacted module in its place (if available) until the impacted module has been corrected. 4. Contact your local Spacelabs Healthcare service and support representative to schedule your device correction as soon as possible. Firm's Support Contact: Phone: 1-800-522-7025 Email: Support@Spacelabs.com Website: https://spacelabshealthcare.com/support/

Root cause

Component change control

Status

Open, Classified

Product code

DSI

Quantity affected

1790

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 countri

Date initiated

2026-02-27

Date posted

2026-04-07

Location

Snoqualmie, WA

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