Recall Z-2077-2014— Spacelabs Healthcare Inc

Name: FDA recall Z-2077-2014
Creator: U.S. Food and Drug Administration
Published: 2014-06-18

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2014-06-18, terminated 2014-12-08. It names one FDA 510(k) clearance: K112173. Product: 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.. Reason: With this software version, the Minimum Alveolar Concentration (MAC) value displayed is extremely high (20.1) and physiologically invalid..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2014-06-18
Terminated: 2014-12-08
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K112173 — SPEACELABS MULTIGAS MODULESpacelabs Healthcare·cleared 2011-10-05

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.