[pending] Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Pending LLM rewrite. Source: FDA_DEVICE Z-1793-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
- Manufacturer
- Spacelabs Healthcare, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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