The Recall Desk
HighFDA (Devices)·Z-2885-2016·Announced 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.

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 involves a risk-of-harm product (failure to alarm for asystole) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Spacelabs Healthcare Inc is recalling the Xhibit Central Station, Model 96102, Version 1.1.2. This medical device is used to display patient vital signs from Xhibit Telemetry Receivers. The recall involves 798 units total, with 488 units distributed in the United States and 310 units distributed outside the US.

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. The affected units were distributed worldwide, including in the US, Puerto Rico, Australia, Canada, China, France, Germany, Ireland, Italy, Netherlands, Philippines, Poland, Romania, Switzerland, and the United Kingdom.

Healthcare facilities should check their inventory for the specific serial numbers listed in the official recall notice. If a unit is affected, the facility should contact Spacelabs Healthcare for instructions on corrective action. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

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.
Manufacturer
Spacelabs Healthcare Inc
Category
Medical Device — Patient Monitoring
Hazard

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 SLA0216F01822
  • SLA0216F01827
  • SLA0416F01924
  • SLA0516F01935
  • SLA0216F01771
  • SLA0216F01773
  • SLA0216F01784
  • SLA0216F01787
  • SLA0416F01897
  • SLA0416F01898
  • SLA0416F01899
  • SLA0416F01905
  • SLA0416F01909
  • SLA0416F01910
  • SLA0416F01911
  • SLA0416F01912
  • SLA0416F01914
  • SLA0416F01915
  • SLA0416F01916
  • SLA0416F01917

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 →

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