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Recall Observatory FDA recall evidence

Device 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.

Z-2261-2020

August 30, 2019

Class II

Product summary

Firm
Spacelabs Healthcare, Inc.
Event
Event 85325
Status
Terminated
Classification
Class II
Quantity
2197 units
Official record key
device-enforcement:Z-2261-2020

Official wording

Reason: The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.

Code information: Model No. 96102 Xhibit Central; Software Versions: 1.3.1, 1.3.2, 1.3.3 and 1.3.4; UDI: 10841522100345

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the 40 states and Puerto Rico, and multiple countries including Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.