The Recall Desk
HighFDA (Devices)·Z-2886-2016·Announced 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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a medical device failure that could prevent the display of critical alarms, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Spacelabs Healthcare Inc is recalling the Xhibit Telemetry Receiver (XTR), Model 96280. The recall involves 316 units total, with 248 units distributed in the United States and 68 units distributed outside the US. The devices are used in conjunction with an Xhibit Central Station to display patient vital signs.

The recall was initiated after the firm received multiple reports of the Xhibit Telemetry System going offline or locking up. Additionally, a single Canadian hospital reported that short-duration asystole alarms may not display an audio and visual alarm. These issues could affect the monitoring of patient vital signs.

Healthcare facilities should check their inventory for the affected serial numbers listed in the official recall notice. If a unit is affected, it should be removed from service and returned to Spacelabs Healthcare Inc for evaluation or replacement.

The recalled product

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.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Serial numbers of units distributed in the US 6280-000053
  • 6280-000056
  • 6280-000057
  • 6280-000058
  • 6280-000059
  • 6280-000066
  • 6280-000067
  • 6280-000068
  • 6280-000077
  • 6280-000078
  • 6280-000079
  • 6280-000083
  • 6280-000084
  • 6280-000085
  • 6280-000086
  • 6280-000088
  • 6280-000090
  • 6280-000092
  • 6280-000093
  • 6280-000095

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Spacelabs Healthcare Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →