Spacelabs Healthcare Inc: Medical Device Recall in 2014 - (Recall #: Z-2077-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 18, 2014

Date Posted: July 23, 2014

Recall Number: Z-2077-2014

Event ID: 68611

Reason for Recall:

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

Status: Terminated

Product Quantity: 8 units total (3 units in US)

Code Information:

Serial Numbers: 2518-000183 2518-000184 2518-000185 2518-000186 2518-000206 2518-000207 2518-000208 2518-000209

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated