FDA Class II Recall: Multi-parameter Command Module, Model 91496, optioned with Masimo… by Spacelabs Healthcare, Inc.

Key facts

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Spacelabs Healthcare, Inc. and the affected product is described in FDA's record as: Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor. FDA's stated reason for the recall is: 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 items listed in FDA's full record). The recall is tracked under FDA recall number Z-1793-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor -- and the recall number Z-1793-2026. If it matches, stop using or distributing it and contact Spacelabs Healthcare, Inc. or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Spacelabs Healthcare, Inc.’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Spacelabs Healthcare, Inc.: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

What is the current status of this recall?

Status as recorded by FDA: Ongoing.

Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Spacelabs Healthcare, Inc. recalled Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor. FDA's record states the reason for recall as: 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 items listed in FDA's full record). The recall is logged under FDA.

How serious is this recall?

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.

Related enforcement actions