FDA Device recall Z-1793-2026
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
- FDA Device
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor by Spacelabs Healthcare, citing 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 measure….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1793-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-27 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Spacelabs Healthcare |
| Distribution | US |
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.
Identifiers
| code_info | Serial Numbers: UDI-DI: 10841522106415, 10841522106422. 1496-223736, 1496-223737, 1496-223738, 1496-224375, 1496-224376…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, 1496-225 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1793-2026%22
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