The Recall Desk

FDA (Devices) recall action 75078

Spacelabs Healthcare Inc recalled 2 products on 2016-10-05

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
2016-10-05
Critical
0
Units
—

Why these products were recalled

The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a single Canadian hospital.

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

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2016-10-05

    Spacelabs Xhibit Telemetry Receiver Recall for System Lockups

    Spacelabs Healthcare is recalling Xhibit Telemetry Receivers because the system may go offline or lock up, potentially failing to display alarms.

    Product
    Spacelabs Healthcare Xhibit Telemetry Receiver (XTR), Model 96280. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2016-10-05

    Spacelabs Xhibit Central Station Recalled for System Lockups and Alarm Failures

    Spacelabs Healthcare is recalling Xhibit Central Stations because the telemetry system may go offline, lock up, or fail to display audio and visual alarms for asystole.

    Product
    Spacelabs Healthcare Xhibit Central Station, Model 96102, Version 1.1.2. Xhibit Telemetry Receivers (XTR) must be connected to an Xhibit Central Station for the display of patient vital signs.
    Category
    Distribution
    1 state