FDA-Device2015-05-20Class II
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.
Spacelabs Healthcare Inc
Hazard
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).
Sold states
distributed in North Carolina, Texas, and Wyoming
Affected count
5 units distributed in the US
Manufactured in
35301 SE Center St, N/A, Snoqualmie, WA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1608-2015Don't want to check this manually?
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