Official recall notice
FDA Recall: Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
- Recall date
- 2026-04-15
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
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.
Recommended action
What to do
1790
Product description
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.