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Ultraview SL Command Module Cardiac Output Defect Recall

Favicon for recalls-rappels.canada.ca Health Canada Recalls & Safety Alerts
Filed March 26th, 2026
Detected April 1st, 2026
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Summary

Health Canada issued a Type II recall for Spacelabs Healthcare's Ultraview SL™ Command Module (model 91496) after production testing discovered the cardiac output function was intermittently yielding bad or irregular curves. Healthcare providers using this multiparameter module should contact the manufacturer for lot information and assess any affected devices in their facilities.

What changed

Health Canada recall RA-81820 identifies Spacelabs Healthcare's Ultraview SL™ Command Module (model 91496) as having a cardiac output function defect discovered during production testing. The multiparameter module was found to intermittently yield bad or irregular curves, presenting a potential performance issue. This is a Type II recall affecting multiple product lots.\n\nHealthcare providers should immediately contact Spacelabs Healthcare (35301 Se Center Street, Snoqualmie, WA 98065) to determine if they have affected units in their facilities. Any devices exhibiting irregular cardiac output readings should be removed from use and the manufacturer contacted for corrective action. Adverse events or safety concerns related to this product should be reported to Health Canada.

What to do next

  1. Contact Spacelabs Healthcare to obtain lot/serial numbers for affected Ultraview SL Command Modules in your facility
  2. Identify and quarantine any model 91496 units exhibiting irregular cardiac output curves
  3. Report any adverse events or patient safety concerns related to this device to Health Canada

Source document (simplified)

Health product recall

Ultraview SL™ Command Module

Brand(s)

Spacelabs Healthcare Inc.

Last updated

2026-04-01

Summary

Product Ultraview SL™ Command Module Issue Medical devices - Performance What to do Contact the manufacturer if you require additional information.

Audience Healthcare

Affected products

| Affected products | Lot or serial number | Model or catalogue number |
| --- | --- | --- |
| Ultraview SL™ Command Module | More than 10 numbers, contact manufacturer. | 91496 |

Issue

It was discovered during production testing that the cardiac output function of the multiparameter module model 91496 was intermittently yielding bad or irregular curves.

Additional information

Details

Original published date:

2026-04-01

Alert / recall type Health product recall Category Health products - Medical devices - Anaesthesiology Companies Spacelabs Healthcare Inc.

35301 Se Center Street, Snoqualmie, Washington, United States, 98065

Published by Health Canada Audience Healthcare Recall class Type II Recall date

2026-03-26

Identification number RA-81820

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Classification

Agency
Health Canada
Filed
March 26th, 2026
Instrument
Enforcement
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
RA-81820

Who this affects

Applies to
Healthcare providers Medical device makers
Industry sector
3345 Medical Device Manufacturing 6211 Healthcare Providers
Activity scope
Medical Device Recall Clinical Equipment Inspection
Geographic scope
Canada CA

Taxonomy

Primary area
Medical Devices
Operational domain
Clinical Operations
Topics
Healthcare Product Safety

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