Recall Z-1145-2015— Spacelabs Healthcare Inc

Name: FDA recall Z-1145-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-28

Class II · Terminated

Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2015-01-28, terminated 2015-12-30. It names one FDA 510(k) clearance: K120616. Product: Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.. Reason: Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset..

Recalling firm: Spacelabs Healthcare Inc
Classification: Class II
Status: Terminated
Initiated: 2015-01-28
Terminated: 2015-12-30
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 Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

Reason for recall

Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset.

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