The Recall Desk
HighFDA (Devices)·Z-0332-2017·Announced 2016-11-09

Spacelabs Xhibit Central Station Recalled for Telemetry Display Issues

Spacelabs Healthcare is recalling 348 Xhibit Central Station units because telemetry SpO2 numerics may drop off the display, though alarms function normally.

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 potential failure to display critical patient data (SpO2) on a medical monitoring device, which poses a risk of harm even though no injuries are explicitly reported in the source text.

Plain-English summary

Spacelabs Healthcare Inc is recalling 348 units of the Xhibit Central Station, Model 96102. The device is intended to provide clinicians with central monitoring of adult, pediatric, and neonatal patient data connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters. The recall affects 292 units in the United States and 56 units outside the United States.

The recall was initiated after the firm received reports that telemetry SpO2 numerics dropped off the Xhibit Central display. The source text notes that desaturation, high, and low limit alarms work normally. The affected units are identified by software version 1.1.5 and specific serial numbers listed in the agency's documentation.

The affected devices were distributed worldwide, including in the United States (specifically to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico) and in Australia, Canada, Chile, Czech Republic, France, Mexico, Netherlands, Panama, Saudi Arabia, Switzerland, Taiwan, and the United Kingdom. Healthcare facilities should contact Spacelabs Healthcare for instructions on how to resolve the issue.

The recalled product

Product
Xhibit Central Station, Model 96102. Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.

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)

  • Software version 1.1.5
  • SLA0216F01808
  • SLA1215F01638
  • SLA1215F01645
  • SLA1215F01652
  • SLA0114F00445
  • SLA0114F00446
  • SLA0114F00447
  • SLA0115F00917
  • SLA0115F00918
  • SLA0115F00919
  • SLA0115F00921
  • SLA0115F00923
  • SLA0115F00924
  • SLA0115F00927
  • SLA0115F00928
  • SLA0115F00934
  • SLA0115F00955
  • SLA0115F00961
  • SLA0115F00968

Distribution