The Recall Desk
SevereFDA (Devices)·Z-2261-2020·Announced 2020-06-10

Spacelabs Xhibit Central Recall for Audio Alarm Loss After Power Failure

Spacelabs Healthcare is recalling Xhibit Central software due to reports of audio alarm loss after power failures or cable disconnections, which could delay alarm recognition.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as a Class II recall involving a medical device where the loss of audio alarms could delay the recognition of critical patient conditions, fitting the criteria for significant injury risk or structural defect.

Plain-English summary

Spacelabs Healthcare, Inc. is recalling Xhibit Central, Model No. 96102, a central monitoring system 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 involves 2,197 units distributed worldwide, including the United States (40 states and Puerto Rico) and multiple countries such as Canada. The affected software versions are 1.3.1, 1.3.2, 1.3.3, and 1.3.4.

The recall was initiated after the firm received reports of loss of audio alarm following a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition. The agency has classified this as a Class II recall.

Clinicians and facilities using this equipment should contact Spacelabs Healthcare for instructions on how to address the issue. The recall number is Z-2261-2020.

The recalled product

Product
Xhibit Central, Model No. 96102 - Product Usage: 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.
Affected units
2,197

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 (5)

  • Model No. 96102 Xhibit Central
  • Software Versions: 1.3.1
  • 1.3.2
  • 1.3.3 and 1.3.4
  • UDI: 10841522100345

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically: