Recall Z-1793-2026
Spacelabs Healthcare, Inc. · initiated February 27, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Codes / lots: Serial Numbers: UDI-DI: 10841522106415, 10841522106422. 1496-223736, 1496-223737, 1496-223738, 1496-224375, 1496-224376, 1496-224400, 1496-224401, 1496-224402, 1496-224403, 1496-224404, 1496-224405, 1496-224406, 1496-223850, 1496-223851, 1496-223852, 1496-224448, 1496-224956, 1496-224957, 1496-224958, 1496-224959, 1496-224960, 1496-224961, 1496-224981, 1496-224258, 1496-223595, 1496-223596, 1496-223597, 1496-223598, 1496-223619, 1496-223620, 1496-223621, 1496-223622, 1496-223623, 1496-223624, 1496-224717, 1496-224718, 1496-223854, 1496-224373, 1496-224374, 1496-223894, 1496-223895, 1496-223896, 1496-223897, 1496-223898, 1496-223899, 1496-223900, 1496-223901, 1496-223902, 1496-223903, 1496-223904, 1496-223905, 1496-223906, 1496-223907, 1496-223918, 1496-225043, 1496-225044, 1496-225045, 1496-225046, 1496-225047, 1496-225048, 1496-225049, 1496-225050, 1496-225051, 1496-225052, 1496-225053, 1496-225054, 1496-225055, 1496-225056, 1496-225057, 1496-225058, 1496-225059, 1496-225060, 1496-225061, 1496-225062, 1496-225063, 1496-225064, 1496-225065, 1496-225066, 1496-225067, 1496-225068, 1496-224949, 1496-223760, 1496-223761, 1496-225154, 1496-224639, 1496-224719, 1496-224720…
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.
FDA-determined cause: Component change control
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/
Details
- Recall number
- Z-1793-2026
- Initiated
- February 27, 2026
- Posted by FDA
- April 7, 2026
- Product code
- DSI – Detector And Alarm, Arrhythmia
- 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.
- Recalling firm
- Spacelabs Healthcare, Inc., Snoqualmie, WA