Agency classClass IIOur severity:High FDA (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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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.
Manufacturer: Spacelabs Healthcare Inc
Category: Medical Device — Patient Monitoring
Hazard: display-failure
data-loss

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

Distributed in 28 states:

Same manufacturer · Spacelabs Healthcare Inc

See all →

Moderate
Spacelabs Xhibit Central Station Recalled for DisplayPort Audio/Video Failures
FDA (Devices) · 2026-08-19
Moderate
Spacelabs SL Command Module patient monitor recall due to manufacturing defect
FDA (Devices) · 2026-05-13
High
Multi-parameter command modules may produce inaccurate cardiac output readings
FDA (Devices) · 2026-04-15
High
Six foot display cables recalled over inadequate shielding and interference
FDA (Devices) · 2025-10-22
High
Twelve foot display cables recalled over inadequate shielding and interference
FDA (Devices) · 2025-10-22

Same hazard · display failure