Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
FDA Recall Z-1793-2026 · Posted 2026-04-07
Recalling FirmSpacelabs Healthcare, Inc.
Recall StatusOpen, Classified
Product CodeDSI
Date Initiated2026-02-27
Product Quantity1790
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.
Firm Action
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: [email protected]
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: [email protected] Website: https://spacelabshealthcare.com/support/
Root Cause
Component change control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.