Spacelabs Healthcare, Inc.: Medical Device Recall in 2020 - (Recall #: Z-2261-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: August 30, 2019

Date Posted: June 10, 2020

Recall Number: Z-2261-2020

Event ID: 85325

Reason for Recall:

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.

Status: Terminated

Product Quantity: 2197 units

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.

Voluntary or Mandated:

Voluntary: Firm initiated