Recall Z-1793-2026 ยท DSI Detector And Alarm, Arrhythmia
Spacelabs Healthcare, Inc.
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
| Date | Apr 7, 2026 (initiated Feb 27, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Component change control |
| 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: 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 t |
| Quantity | 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 countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103142 | SPACELABS MULTI-PARAMETER MODULE Spacelabs Healthcare, Inc., Mar 3, 2011 |