Recall Z-0351-2014— Spacelabs Healthcare, Llc

Name: FDA recall Z-0351-2014
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 2014-04-02. It names one FDA 510(k) clearance: K120616. Product: Spacelabs Healthcare qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.. Reason: Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component..

Recalling firm: Spacelabs Healthcare, Llc
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Terminated: 2014-04-02
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 qube Compact Patient Monitor, Model 91390. It is a patient monitor with arrhythmia detection or alarms. The qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications.

Reason for recall

Spacelabs Healthcare qube Compact Patient Monitor, Model 91390, may fail to power ON due to incorrect programmed microcontroller component.

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