The Recall Desk

FDA (Devices) recall action 70453

Spacelabs Healthcare Inc recalled 2 products on 2015-03-04

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-03-04
Critical
0
Units
—

Why these products were recalled

Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or reset.

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.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2015-03-04

    Spacelabs XPREZZON Bedside Monitors Recalled for Boot Failure

    Spacelabs Healthcare is recalling XPREZZON Bedside Monitors because they may fail to boot up or reset to factory defaults after power on.

    Product
    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends…
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-03-04

    Spacelabs Healthcare Recalls qube Compact Monitors for Boot Failure

    Spacelabs Healthcare is recalling 2,955 qube Compact Monitors because they may fail to boot up or reset to factory defaults after power on.

    Product
    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…
    Category
    Distribution
    0 states