Recall Z-1793-2026— Spacelabs Healthcare, Inc.
Class II · Ongoing
Class II FDA medical device recall by Spacelabs Healthcare, Inc., initiated 2026-02-27. It names one FDA 510(k) clearance: K103142. Product: Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor. 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..
- Recalling firm
- Spacelabs Healthcare, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-27
- Firm location
- Snoqualmie, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.