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Spacelabs Healthcare Inc recalls Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passivel
Recalled May 20, 2015 · FDA recall Z-1608-2015 · Spacelabs Healthcare
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). · FDA Class II
Units
5 units distributed in the US
Sold at
distributed in North Carolina, Texas, and Wyoming
Description
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).
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.
Manufacturer(s)
Spacelabs Healthcare Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →