Recall Z-0188-2014— Spacelabs Healthcare, Llc

Name: FDA recall Z-0188-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-17

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare, Llc, initiated 2013-10-17, terminated 2014-02-25. It names one FDA 510(k) clearance: K120616. Product: Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.. Reason: Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors..

Recalling firm: Spacelabs Healthcare, Llc
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Terminated: 2014-02-25
Firm location: Snoqualmie, WA, United States

510(k) clearances named in this recall

1 on FDA's record

K120616 — SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390Spacelabs Medical, Inc.·cleared 2012-03-29

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 elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

Reason for recall

Spacelabs Healthcare elance Vital Signs Monitor with Option S, model 93330, is recalled because the monitor will not permit connection of any of the Spacelabs TruLink line of SpO2 sensors.

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