Ultraview SL recallZ-1793-2026 · Spacelabs Healthcare, Inc. · initiated Feb 27, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Spacelabs Healthcare, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Component change control
What the company is doing
On 2/27/2026, correction notices were emailed to customers who were asked to do the following: 1. Notify all relevant employees within your organization. If products were further distributed, please forward the notice to these sites/customers. 2. Complete and return the acknowledgement form via email to: [email protected] 3. Instruct staff who utilize the cardiac output feature to use the "Manual" mode, or use a non-impacted module in its place (if available) until the impacted module has been corrected. 4. Contact your local Spacelabs Healthcare service and support representative to schedule your device correction as soon as possible. Firm's Support Contact: Phone: 1-800-522-7025 Email: [email protected] Website: https://spacelabshealthcare.com/support/
Recall details
- Recall number
- Z-1793-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 27, 2026
- Posted by the FDA
- Apr 7, 2026
- Recalling firm
- Spacelabs Healthcare, Inc.
- Quantity
- 1790
- Product code
- DSI
- FDA submissions
- K103142
- Distribution
- Worldwide - US Nationwide distribution including in the states of 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 and the countries of TAIWAN, CANADA, KUWAIT, FRANCE, SAUDI ARABIA, POLAND, PAKISTAN, MEXICO, ARGENTINA, PANAMA.
Product description
Multi-parameter Command Module, Model 91496, optioned with Masimo or Nellcor
Code information (models, lots, serial numbers)
Show the full code information (23k characters)
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Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- Ultraview SL Ultraview SL®Spacelabs Healthcare (Washington), Inc · SYSTEM, MEASUREMENT, BLOOD-PRESSURE, NON-INVASIVE2 recalls2 reports
- Ultraview SL UV SL Command ModuleSpacelabs Healthcare (Washington), Inc · DETECTOR AND ALARM, ARRHYTHMIA1 recall3 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page