Spacelabs Healthcare Inc recalls Spacelabs Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), function…

Recall date

January 28, 2015

Source

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

Recall number

Z-1145-2015

FDA classification

Class II

Brand / firm

Spacelabs Healthcare Inc

Sold / distributed

Worldwide Distribution.

Why it was recalled

Spacelabs Healthcare qube Bedside Monitors, Model 91390, are recalled because the firm has received multiple reports of qube monitors failing to boot up or returning to factory default configuration settings following power on or reset.

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 Healthcare qube Compact Monitor, Model 91390. The Spacelabs Healthcare qube Compact Monitor (91390), 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. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.