Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Spacelabs Healthcare Ultraview SL Multigas Module Recalled by Spacelabs Healthcare Inc Due to With this software version, the Minimum Alveolar Concentration...

Date: June 18, 2014
Company: Spacelabs Healthcare Inc
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Spacelabs Healthcare Inc directly.

Affected Products

Spacelabs Healthcare Ultraview SL Multigas Module, Model 92518 (Software V1.00.00-09). Provides a means of monitoring a variety of gas concentrations and alert clinical personnel when the concentration of anesthetic agent(s), oxygen, carbon dioxide or nitrous oxide moves outside of user-defined limits.

Quantity: 8 units total (3 units in US)

Why Was This Recalled?

With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid.

Where Was This Sold?

Worldwide Distribution - US in the state of Georgia and in the countries of : Malaysia, Paraguay, and France.

About Spacelabs Healthcare Inc

Spacelabs Healthcare Inc has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report