Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | February 27, 2026 |
| Reported | April 15, 2026 |
| Recalling firm | Spacelabs Healthcare, Inc. |
| Country / region | United States WA |
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.
Affected products
- Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
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