FDA recall, , Moderate risk
Spacelabs Healthcare Multi-Parameter Command Module
The Multi-parameter Command Module has a circuit board issue that may cause inaccurate readings and delayed care.
Summary by Recall Canary from the FDA notice
What happened
Spacelabs Healthcare, Inc., of Snoqualmie, Washington, began a recall on February 27, 2026, of its Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor, due to a circuit board issue.
In Auto mode, Cardiac Output measurement may activate early, causing 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 for additional readings, potentially leading to delayed care and/or fluid overload.
The FDA added the recall to its Enforcement Report on April 7, 2026, with nationwide distribution including states such as New York, New Jersey, and Texas, and international distribution to countries including Canada, France, and Mexico.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number and UDI-DI are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Multi-parameter Command Module
- Model number
- 91496
- optioned with Masimo or Nellcor
- UDI-DI
- 10841522106415
- 10841522106422
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of New York, New Jersey, Alabama, Oklahoma, Iowa, Montana, Wyoming, Minnesota, Texas, Wisconsin, Pennsylvania, Washington, Oregon, Michigan, California, South Carolina, Idaho, Florida, Mississippi, Kansas, South Dakota, Louisiana, Ohio, Missouri, New Hampshire, Georgia, Maryland, Tennessee, Arizona, PR and the countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA.
- Company
- Spacelabs Healthcare, Inc.Snoqualmie, Washington
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98374
- Recall number
- Z-1793-2026
All recalls from Spacelabs Healthcare, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
