FDAMay 8, 2015device

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 ...

Official recall recorded by the U.S. Food & Drug Administration.

The 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).

What to do

FDA enforcement status: Terminated

Brands named

spacelabs healthcarespacelabs

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 ... — Recall Details · AllClear