Recall Z-1608-2015— Spacelabs Healthcare Inc
Class II · Terminated
Class II FDA medical device recall by Spacelabs Healthcare Inc, initiated 2015-05-08, terminated 2015-11-05. It names one FDA 510(k) clearance: K120616. Product: Spacelabs qube Compact Monitor, Model 91390. The monitor is 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.. Reason: The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013)..
- Recalling firm
- Spacelabs Healthcare Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-08
- Terminated
- 2015-11-05
- Firm location
- Snoqualmie, WA, United States
510(k) clearances named in this recall
1 on FDA's recordK-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 qube Compact Monitor, Model 91390. The monitor is 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.
Reason for recall
The input power can fail even though the power source at the wall has not been interrupted. In addition, there is the potential for the qube Compact Monitor to fail to turn on. This is a retrospective recall related to a recall initiated in 2012 (Z-0403-2013).
Data sourced from openFDA. This site is unofficial and independent of the FDA.