Spacelabs Healthcare Inc recalls Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passivel…

Recall date

May 8, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1608-2015

FDA classification

Class II

Brand / firm

Spacelabs Healthcare Inc

Sold / distributed

distributed in North Carolina, Texas, and Wyoming

Why it was recalled

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).

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.