Quick Facts at a Glance
- Recall Date
- February 27, 2026
- Hazard Level
- HIGH
- Brand
- Spacelabs Healthcare
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Spacelabs Healthcare
- Product type
- Multi-parameter Patient Monitor Module
- Model numbers
- Serial Numbers: UDI-DI: 10841522106415, 10841522106422. 1496-223736, 1496-223737, 1496-223738, 1496-224375, 1496-224376, 1496-224400, 1496-224401 +12 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 27, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Spacelabs Healthcare, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The Multi-parameter Command Module 91496 is a critical component used with Masimo or Nellcor configurations to perform multi-parameter monitoring.
Why This Is Dangerous
A circuit-board defect can cause CO readings to activate early in Auto mode, producing erroneous readings and potential delays in care or fluid overload.
Industry Context
This recall is not identified as part of a broader industry pattern.
Real-World Impact
Affected patients and healthcare providers may experience delays in diagnosis or treatment due to inaccurate monitoring readings.
Practical Guidance
How to identify if yours is affected
- Locate the model 91496 and check if the Masimo or Nellcor option is present.
- Review serial numbers and UDI-DI as listed in the recall documents.
- Verify the device was distributed worldwide including US states listed in the recall.
Where to find product info
Check the FDA recall page and manufacturer notification letter for exact serials and identifiers.
What timeline to expect
Refunds or replacements will follow the manufacturer’s recall process, timelines not specified.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- File a formal complaint with CP SC if unresponsive.
- Consider seeking legal counsel for injury-related or significant delays.
How to prevent similar issues
- Ensure future devices have robust Auto mode validation for cardiac output.
- Track recalls via FDA and manufacturer notices.
- Avoid using recalled medical devices in clinical decision making until cleared.
Documentation advice
Keep recall letter, serial numbers, and communication logs.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model: 91496 with Masimo or Nellcor option. Quantity: 1,790 units. Distribution: Worldwide including U.S. states NY, NJ, AL, OK, IA, MT, WY, MN, TX, WI, PA, WA, OR, MI, CA, SC, ID, FL, MS, KS, SD, LA, OH, MO, NH, GA, MD, TN, AZ, PR; Countries: Taiwan, Canada, Kuwait, France, Saudi Arabia, Poland, Pakistan, Mexico, Argentina, Panama.
Reported Incidents
No specific incidents or injuries are detailed in the provided recall notice.
Key Facts
- Hazard level: HIGH
- Model/UDI-Specific serial ranges provided
- Worldwide distribution including US states and several countries
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.